Delivering a constricting cord to a cardiac valve annulus using balloon-assisted positioning

ABSTRACT

A constricting cord can be delivered to the vicinity of an annulus using an apparatus that includes a set of support arms, with a respective anchor launcher supported by each of the support arms. An inflatable first balloon is configured to push the support arms away from each other when the first balloon is inflated. An inflatable second balloon is mounted to a shaft and is configured for inflation when the second balloon is disposed distally beyond the first balloon. In some embodiments, the distal balloon is inflated while it is in a ventricle. In some embodiments, the distal balloon is inflated while it is in a pulmonary artery.

CROSS REFERENCE TO RELATED APPLICATIONS

This Application claims the benefit of U.S. Provisional Application62/395,357, filed Sep. 15, 2016, and U.S. Provisional Application62/519,529, filed Jun. 14, 2017, each of which is incorporated herein byreference in its entirety.

BACKGROUND

A variety of approaches for delivering and installing a cinching cord oran annulus ring to a cardiac valve annulus are described in U.S.application Ser. No. 14/364,060 (published as US 2014/0309730) and Ser.No. 14/895,711 (published as US 2016/0120645), each of which isincorporated by reference herein in its entirety.

SUMMARY OF THE INVENTION

One aspect of the invention is directed to a first apparatus fordelivering a cinching cord to the vicinity of an annulus. The firstapparatus comprises an elongated core, at least four support arms, andat least four anchor launchers. The elongated core has (a) a distal end,(b) a main channel that runs through the core in a proximal-to-distaldirection, (c) at least four first channels that run through the core ina proximal-to-distal direction, each of the first channels beingdimensioned to accommodate a respective pull wire, and (d) at least onesecond channel that runs through the core in a proximal-to-distaldirection, dimensioned to accommodate a first proximal portion and asecond proximal portion of a cinching cord. The at least four supportarms are mounted to the core and extend distally beyond the distal endof the core. Each of the anchor launchers has a distal end, and each ofthe anchor launchers is supported by a respective one of the supportarms.

The support arms are configured to support arms hold the distal ends ofthe anchor launchers at positions that correspond to a shape of theannulus, with the distal ends of the anchor launchers distributed abouta perimeter of the shape of the annulus.

Some embodiments of the first apparatus further comprise at least fouranchors, a cinching cord, and at least four pull wires. Each of theanchors is disposed in a respective one of the anchor launchers. Thecinching cord has a distal loop portion, a first proximal portion, and asecond proximal portion, wherein the first proximal portion and thesecond proximal portion are disposed in the at least one second channel,and wherein the anchors are connected to the distal loop portion of thecinching cord. Each of the pull wires is disposed in a respective one ofthe first channels, wherein each of the pull wires is operativelyconnected to a respective one of the anchor launchers so that pulling ona respective pull wire will launch the respective anchor.

Some embodiments of the first apparatus further comprise a plurality ofsupport rings and a plurality of support rods. The support arms areaffixed to the support rings and extend in a distal direction from thesupport rings. The support rods are affixed to the support rings, andthe support rods extend in a proximal direction from the support rings.In these embodiments, the core has a plurality of third channels thatrun through the core in a proximal-to-distal direction and aredimensioned to accommodate the support rods, and the support arms aremounted to the core by inserting the support rods into the thirdchannels. Optionally, these embodiments further comprise a radio-opaquematerial distributed on the support rods in an asymmetric pattern.

In some embodiments of the first apparatus, the main channel is centeredabout the radial center of the core. In some embodiments of the firstapparatus, each of the first channels and each of the at least onesecond channel is located at the same radial distance from the radialcenter of the core. In some embodiments of the first apparatus, each ofthe first channels comprises a lumen, and each of the at least onesecond channel comprises a lumen. In some embodiments of the firstapparatus, each of the first channels and each of the at least onesecond channel is located at the same radial distance from the radialcenter of the core, each of the first channels comprises a lumen, andeach of the at least one second channel comprises a lumen.

In some embodiments of the first apparatus, the at least four supportarms comprises at least eight support arms, the at least four firstchannels comprises at least eight first channels, and the at least fouranchor launchers comprises at least eight anchor launchers. In someembodiments of the first apparatus, the annulus is a mitral valveannulus. In other embodiments of the first apparatus, the annulus is atricuspid valve annulus.

Some embodiments of the first apparatus further comprise an outer sleevedisposed around the core, the outer sleeve having a distal end. Theouter sleeve is slidable with respect to the core between an extendedposition and a retracted position. When the outer sleeve is in theextended position, the support arms and the anchor launchers aredisposed within the outer sleeve. When the outer sleeve is in theretracted position, the anchor launchers and at least a portion of thesupport arms extend distally beyond the distal end of the outer sleeve.

Some embodiments of the first apparatus further comprise a first sleevedisposed around the core, the first sleeve having a distal portion,wherein the first sleeve is slidable with respect to the core between anextended position and a retracted position; and a removable secondsleeve slidably disposed around the distal portion of the first sleeve.When the second sleeve is in an initial position, the support arms andthe anchor launchers are disposed within the second sleeve, and when thesecond sleeve is removed and the first sleeve is in the retractedposition, the anchor launchers are free to move to positions thatcorrespond to the shape of the annulus.

Another aspect of the invention is directed to a second apparatus fordelivering a cinching cord to the vicinity of an annulus. The secondapparatus comprises an elongated core, at least support arms, and atleast eight anchor launchers. The elongated core has (a) a distal end,(b) a main channel that runs through the core in a proximal-to-distaldirection, (c) at least eight first channels that run through the corein a proximal-to-distal direction at positions that are radially beyondthe main channel, each of the first channels being dimensioned toaccommodate a respective pull wire, and (d) a plurality of secondchannels that run through the core in a proximal-to-distal direction atpositions that are radially beyond the main channel, each of the secondchannels being dimensioned to accommodate a respective proximal portionof a cinching cord. The at least eight support arms are mounted to thecore and extend distally beyond the distal end of the core. Each of theanchor launchers has a distal end, and each of the anchor launchers issupported by a respective one of the support arms. The support arms areconfigured to hold the distal ends of the anchor launchers at positionsthat correspond to a shape of the annulus, with the distal ends of theanchor launchers distributed about a perimeter of the shape of theannulus.

Some embodiments of the second apparatus further comprise at least eightanchors, a cinching cord, and at least eight pull wires. Each of theanchors is disposed in a respective one of the anchor launchers. Thecinching cord has a distal loop portion, a first proximal portion, and asecond proximal portion, wherein the first proximal portion and thesecond proximal portion are disposed in respective ones of the secondchannels, and wherein the at least eight anchors are connected to thedistal loop portion of the cinching cord. Each of the pull wires isdisposed in a respective one of the first channels, and each of the pullwires is operatively connected to a respective one of the anchorlaunchers so that pulling on a respective pull wire will launch therespective anchor.

Some embodiments of the second apparatus further comprise a plurality ofsupport rings and a plurality of support rods. The support arms areaffixed to the support rings and extend in a distal direction from thesupport rings. The support rods are affixed to the support rings, andthe support rods extend in a proximal direction from the support rings.In these embodiments, the core has a plurality of third channels thatrun through the core in a proximal-to-distal direction and aredimensioned to accommodate the support rods, and the support arms aremounted to the core by inserting the support rods into the thirdchannels. Optionally, these embodiments further comprise a radio-opaquematerial distributed on the support rods in an asymmetric pattern.

In some embodiments of the second apparatus, each of the first channelsis located at the same radial distance from the radial center of thecore. In some embodiments of the second apparatus, each of the firstchannels and each of the second channels is located at the same radialdistance from the radial center of the core. In some embodiments of thesecond apparatus, each of the first channels comprises a lumen and eachof the second channels comprises a lumen.

Some embodiments of the second apparatus further comprise a plurality ofsupport rings, a plurality of support rods, and a radio opaque material.The support arms are affixed to the support rings and extend in a distaldirection from the support rings. The support rods are affixed to thesupport rings, and the support rods extend in a proximal direction fromthe support rings. The radio-opaque material is distributed on thesupport rods in an asymmetric pattern. In these embodiments, the corehas a plurality of third channels that run through the core in aproximal-to-distal direction and are dimensioned to accommodate thesupport rods, and the support arms are mounted to the core by insertingthe support rods into the third channels. In these embodiments, each ofthe first channels and each of the second channels is located at thesame radial distance from the radial center of the core, each of thefirst channels comprises a lumen, and each of the second channelscomprises a lumen.

Some embodiments of the second apparatus further comprise an outersleeve disposed around the core, the outer sleeve having a distal end.The outer sleeve is slidable with respect to the core between anextended position and a retracted position. When the outer sleeve is inthe extended position, the support arms and the anchor launchers aredisposed within the outer sleeve. When the outer sleeve is in theretracted position, the anchor launchers and at least a portion of thesupport arms extend distally beyond the distal end of the outer sleeve.

Some embodiments of the second apparatus further comprise a first sleevedisposed around the core, the first sleeve having a distal portion,wherein the first sleeve is slidable with respect to the core between anextended position and a retracted position; and a removable secondsleeve slidably disposed around the distal portion of the first sleeve.When the second sleeve is in an initial position, the support arms andthe anchor launchers are disposed within the second sleeve, and when thesecond sleeve is removed and the first sleeve is in the retractedposition, the anchor launchers are free to move to positions thatcorrespond to the shape of the annulus.

Another aspect of the invention is directed to a third apparatus fordelivering an annulus ring to the vicinity of an annulus. The thirdapparatus comprises an elongated core, at least four support arms, andat least four anchor launchers. The elongated core has (a) a distal end,(b) a main channel that runs through the core in a proximal-to-distaldirection, and (c) at least four lumens that run through the core in aproximal-to-distal direction. Each of the lumens is dimensioned toaccommodate a respective pull wire. The support arms are mounted to thecore and extend distally beyond the distal end of the core. Each of theanchor launchers has a distal end, and each of the anchor launchers issupported by a respective one of the support arms. The support arms areconfigured to hold the distal ends of the anchor launchers at positionsthat correspond to a shape of the annulus, with the distal ends of theanchor launchers distributed about a perimeter of the shape of theannulus.

Some embodiments of the third apparatus further comprise at least fouranchors, an annulus ring, and at least four pull wires. In theseembodiments, each of the anchors is disposed in a respective one of theanchor launchers and the anchors are connected to the annulus ring. Eachof the pull wires is disposed in a respective one of the lumens, andeach of the pull wires is operatively connected to a respective one ofthe anchor launchers so that pulling on a respective pull wire willlaunch the respective anchor.

Some embodiments of the third apparatus further comprise a plurality ofsupport rings and a plurality of support rods. In these embodiments, thesupport arms are affixed to the support rings and extend in a distaldirection from the support rings. The support rods are affixed to thesupport rings, and the support rods extend in a proximal direction fromthe support rings. The core has a plurality of support channels that runthrough the core in a proximal-to-distal direction and are dimensionedto accommodate the support rods, and the support arms are mounted to thecore by inserting the support rods into the support channels.Optionally, these embodiments further comprise a radio-opaque materialdistributed on the support rods in an asymmetric pattern.

In some embodiments of the third apparatus, the main channel is centeredabout the radial center of the core and each of the lumens is located atthe same radial distance from the radial center of the core. In someembodiments of the third apparatus, the at least four support armscomprises at least eight support arms, the at least four lumenscomprises at least eight lumens, and the at least four anchor launcherscomprises at least eight anchor launchers.

Some embodiments of the third apparatus further comprise an outer sleevedisposed around the core, the outer sleeve having a distal end. Theouter sleeve is slidable with respect to the core between an extendedposition and a retracted position. When the outer sleeve is in theextended position, the support arms and the anchor launchers aredisposed within the outer sleeve. When the outer sleeve is in theretracted position, the anchor launchers and at least a portion of thesupport arms extend distally beyond the distal end of the outer sleeve.

Some embodiments of the third apparatus further comprise a first sleevedisposed around the core, the first sleeve having a distal portion,wherein the first sleeve is slidable with respect to the core between anextended position and a retracted position; and a removable secondsleeve slidably disposed around the distal portion of the first sleeve.When the second sleeve is in an initial position, the support arms andthe anchor launchers are disposed within the second sleeve, and when thesecond sleeve is removed and the first sleeve is in the retractedposition, the anchor launchers are free to move to positions thatcorrespond to the shape of the annulus.

Another aspect of the invention is directed to a fourth apparatus forinstalling a cinching cord onto an annulus or onto tissue adjacent tothe annulus. The fourth apparatus includes a housing, an elongated core,a cinching cord, at least four anchors, and first and second extensionsections of cord. The elongated core is mounted with respect to thehousing. The core has (a) a distal end, (b) a proximal end, (c) a firstlumen that runs through the core in a proximal-to-distal direction, and(d) a second lumen that runs through the core in a proximal-to-distaldirection. The cinching cord has a distal loop portion, a first proximalportion, and a second proximal portion, wherein the first proximalportion of the cinching cord extends distally beyond the distal end ofthe core, runs through the first lumen, and extends proximally beyondthe proximal end of the core, and wherein the second proximal portion ofthe cinching cord extends distally beyond the distal end of the core,runs through the second lumen, and extends proximally beyond theproximal end of the core. The anchors are configured to anchor thedistal loop portion of the cinching cord into the annulus or into tissueadjacent to the annulus. The first extension section of cord has adistal end and a proximal section, wherein the distal end of the firstextension section is connected to the first proximal portion of thecinching cord. The second extension section of cord has a distal end anda proximal section, wherein the distal end of the second extensionsection is connected to the second proximal portion of the cinchingcord. The first lumen is dimensioned to slidably accommodate the firstproximal portion of the cinching cord and the first extension section ofcord, and the second lumen is dimensioned to slidably accommodate thesecond proximal portion of the cinching cord and the second extensionsection of cord. The cinching cord, the first and second extensionsections of cord, and the first and second lumens are configured so thatafter the distal loop portion of the cinching cord is anchored to theannulus or into the tissue adjacent to the annulus by the at least fouranchors, progressive movement of the housing in a proximal directionwill (a) cause the core to progressively move in a proximal directionwith respect to the first and second proximal portions of the cinchingcord and (b) cause the first and second extension sections of cord to beprogressively drawn into the first and second lumens, respectively.

In some embodiments of the fourth apparatus, the cinching cord, thefirst extension section of cord, and the second extension section ofcord are contiguous sections of a single cord.

Some embodiments of the fourth apparatus further comprise at least onespool rotatably mounted with respect to the housing. In theseembodiments, the proximal section of the first extension section of cordis wound on the at least one spool, and the proximal section of thesecond extension section of cord is wound on the at least one spool. Thecinching cord, the first and second extension sections of cord, thefirst and second lumens, and the at least one spool are configured sothat after the distal loop portion of the cinching cord is anchored tothe annulus or into the tissue adjacent to the annulus by the at leastfour anchors, progressive movement of the housing in a proximaldirection will cause the first and second extension sections of cord toprogressively unwind from the at least one spool.

Some embodiments of the fourth apparatus further comprise a lock thatselectively either (a) prevents the at least one spool from rotating or(b) allows the at least one spool to rotate. In these embodiments, theat least one spool has spokes or markings that enhance visibility ofrotation of the at least one spool, and the at least one spool isarranged with respect to the housing so that at least a portion of thespokes or markings is visible from outside the housing. The cinchingcord, the first extension section of cord, and the second extensionsection of cord are contiguous sections of a single cord.

Another aspect of the invention is directed to a fifth apparatus forinstalling a cinching cord onto an annulus or onto tissue adjacent tothe annulus. The fifth apparatus comprises a housing, at least onespool, an elongated core, a cinching cord, at least four anchors, atleast four anchor launchers, at least four support arms, and first andsecond extension sections of cord. The at least one spool is rotatablymounted with respect to the housing. The elongated core is mounted withrespect to the housing. The core has (a) a distal end, (b) a proximalend, (c) a first lumen that runs through the core in aproximal-to-distal direction, and (d) a second lumen that runs throughthe core in a proximal-to-distal direction. The cinching cord has adistal loop portion, a first proximal portion, and a second proximalportion, wherein the first proximal portion of the cinching cord extendsdistally beyond the distal end of the core, runs through the firstlumen, and extends proximally beyond the proximal end of the core, andwherein the second proximal portion of the cinching cord extendsdistally beyond the distal end of the core, runs through the secondlumen, and extends proximally beyond the proximal end of the core. Theanchors are configured to anchor the distal loop portion of the cinchingcord into the annulus or into tissue adjacent to the annulus. Each ofthe anchor launchers is configured to launch a respective one of the atleast four anchors into the annulus or into the tissue adjacent to theannulus, and each of the anchor launchers has a distal end. The supportarms are mounted to the core and extend distally beyond the distal endof the core and support the anchor launchers. The support arms areshaped to hold the distal ends of the anchor launchers at positions thatcorrespond to a shape of the annulus, with the distal ends of the anchorlaunchers distributed about a perimeter of the shape of the annulus. Thefirst extension section of cord has a distal end and a proximal section.The distal end of the first extension section is connected to the firstproximal portion of the cinching cord, and the proximal section of thefirst extension section is wound on the at least one spool. The secondextension section of cord has a distal end and a proximal section, andthe distal end of the second extension section is connected to thesecond proximal portion of the cinching cord. The proximal section ofthe second extension section is wound on the at least one spool. Thefirst lumen is dimensioned to slidably accommodate the first proximalportion of the cinching cord and the first extension section of cord,and the second lumen is dimensioned to slidably accommodate the secondproximal portion of the cinching cord and the second extension sectionof cord. The cinching cord, the first and second extension sections ofcord, the first and second lumens, and the at least one spool areconfigured so that after the distal loop portion of the cinching cord isanchored to the annulus or into the tissue adjacent to the annulus bythe at least four anchors, progressive movement of the housing in aproximal direction will (a) cause the core to progressively move in aproximal direction with respect to the first and second proximalportions of the cinching cord and (b) cause the first and secondextension sections of cord to progressively unwind from the at least onespool and be progressively drawn into the first and second lumens,respectively.

In some embodiments of the fifth apparatus, the cinching cord, the firstextension section of cord, and the second extension section of cord arecontiguous sections of a single cord. In some of these embodiments, thesingle cord is an ultra high molecular weight polyethylene cord. Inother embodiments of the fifth apparatus, the distal end of the firstextension section of cord is fastened to the first proximal portion ofthe cinching cord, and wherein the distal end of the second extensionsection of cord is fastened to the second proximal portion of thecinching cord.

Some embodiments of the fifth apparatus further comprise a lock thatselectively either (a) prevents the at least one spool from rotating or(b) allows the at least one spool to rotate. In some of theseembodiments, the lock comprises a removable pin that prevents the atleast one spool from rotating when the pin is installed, and allows theat least one spool to rotate when the pin is removed.

In some embodiments of the fifth apparatus, the at least one spool isarranged with respect to the housing so that at least a portion of theat least one spool is visible from outside the housing. In someembodiments of the fifth apparatus, the at least one spool has spokes ormarkings that enhance visibility of rotation of the at least one spool,and the at least one spool is arranged with respect to the housing sothat at least a portion of the spokes or markings is visible fromoutside the housing.

In some embodiments of the fifth apparatus, the at least one spoolcomprises a first spool upon which the proximal section of the firstextension section of cord is wound, and a second spool upon which theproximal section of the second extension section of cord is wound. Insome embodiments of the fifth apparatus, the at least one spoolcomprises a single spool having (a) a first region upon which theproximal section of the first extension section of cord is wound and (b)a second region upon which the proximal section of the second extensionsection of cord is wound, wherein the first region and the second regionare non-overlapping. In some embodiments of the fifth apparatus, thefirst lumen and the second lumen have smooth polymer walls.

Some embodiments of the fifth apparatus further comprise at least fourpull wires and a spring-loaded actuator. Each of the pull wires has aproximal end and a distal end, wherein the distal end of each of thepull wires is operatively connected to a respective one of the anchorlaunchers such that pulling the respective pull wire in a proximaldirection causes the respective anchor launcher to launch a respectiveanchor. The spring-loaded actuator is configured to hold the proximalends of each of the pull wires steady prior to actuation of a trigger,and to pull the proximal ends of each of the pull wires in a proximaldirection upon actuation of the trigger.

In some embodiments of the fifth apparatus, the at least four anchorscomprises at least eight anchors, the at least four anchor launcherscomprises at least eight anchor launchers, and the at least four supportarms comprises at least eight support arms. In some embodiments of thefifth apparatus, the annulus is a mitral valve annulus. In otherembodiments of the fifth apparatus, the annulus is a tricuspid valveannulus.

Some embodiments of the fifth apparatus further comprise a lock thatselectively either (a) prevents the at least one spool from rotating or(b) allows the at least one spool to rotate. In these embodiments, theat least one spool has spokes or markings that enhance visibility ofrotation of the at least one spool, and the at least one spool isarranged with respect to the housing so that at least a portion of thespokes or markings is visible from outside the housing. The cinchingcord, the first extension section of cord, and the second extensionsection of cord are contiguous sections of a single cord. In addition,the at least four anchors comprises at least eight anchors, the at leastfour anchor launchers comprises at least eight anchor launchers, and theat least four support arms comprises at least eight support arms.

In some embodiments of the fifth apparatus, the at least one spoolcomprises a single spool having (a) a first region upon which theproximal section of the first extension section of cord is wound and (b)a second region upon which the proximal section of the second extensionsection of cord is wound, and the first region and the second region arenon-overlapping.

Some embodiments of the fifth apparatus further comprise an outer sleevedisposed around the core, the outer sleeve having a distal end. Theouter sleeve is slidable with respect to the core between an extendedposition and a retracted position. When the outer sleeve is in theextended position, the support arms and the anchor launchers aredisposed within the outer sleeve. And when the outer sleeve is in theretracted position, the anchor launchers and at least a portion of thesupport arms extend distally beyond the distal end of the outer sleeve.Some of these embodiments further comprise a rack and pinion mountedwith respect to the housing, with the rack connected to the outer sleevesuch that actuation of the pinion causes the outer sleeve to movebetween the extended position and the retracted position.

Some embodiments of the fifth apparatus further comprise a first sleevedisposed around the core, the first sleeve having a distal portion,wherein the first sleeve is slidable with respect to the core between anextended position and a retracted position; and a removable secondsleeve slidably disposed around the distal portion of the first sleeve.When the second sleeve is in an initial position, the support arms andthe anchor launchers are disposed within the second sleeve, and when thesecond sleeve is removed and the first sleeve is in the retractedposition, the anchor launchers are free to move to positions thatcorrespond to the shape of the annulus.

Another aspect of the invention is directed to a first method forpreventing tissue ingrowth from interfering with the cinching of anannulus using a cinching cord. The cinching cord has a distal loopportion disposed within a sleeve that promotes tissue ingrowth, a firstproximal portion, and a second proximal portion. The first methodcomprises manipulating the cinching cord so that (a) the distal loopportion of the cinching cord disposed within the sleeve is in thevicinity of the annulus and (b) the first and second proximal portionsof the cinching cord run in a proximal direction from the distal loopportion of the cinching cord. The first method also comprises anchoringthe distal loop portion of the cinching cord to at least one of theannulus and tissue adjacent to the annulus, and covering the first andsecond proximal portions of the cinching cord with a material thatresists tissue ingrowth. The first method also comprises, subsequent tothe anchoring step and the covering step, waiting for tissue ingrowth tostrengthen a bond between the distal loop portion of the cinching cordand at least one of the annulus and the tissue adjacent to the annulus.The first method also comprises, subsequent to the waiting step,cinching the annulus by pulling the first and second proximal portionsof the cinching cord so as to reduce a diameter of the annulus. Thefirst method also comprises, subsequent to the cinching step, fasteningthe cinching cord so that the cinching cord holds the annulus in areduced diameter state. Preferably, the covering step comprises slidingan elongated cord protector having a first lumen and a second lumen overthe first and second proximal portions of the cinching cord so that thefirst proximal portion of the cinching cord passes through the firstlumen and that the second proximal portion of the cinching cord passesthrough the second lumen.

Some embodiments of the first method further comprise threading thefirst proximal portion of the cinching cord through the first lumenusing a first threading cord and threading the second proximal portionof the cinching cord through the second lumen using a second threadingcord. In these embodiments, prior to the threading steps, the firstthreading cord is disposed in the first lumen and the second threadingcord is disposed in the second lumen. In these embodiments, in thesliding step, the first and second proximal portions of the cinchingcord operate as guidewires over which the elongated cord protector isslid, and the elongated cord protector is slid into a position at whicha distal end of the elongated cord protector is adjacent to the distalloop portion of the cinching cord.

Some embodiments of the first method further comprise the step ofremoving the elongated cord protector subsequent to the waiting step andprior to the cinching step. Some embodiments of the first method furthercomprise the step of sliding a stiffening member in a proximal to distaldirection through a third lumen that runs through the elongated cordprotector, wherein the sliding step is implemented subsequent to theanchoring step and prior to the covering step.

In some embodiments of the first method, the cinching step comprisesadvancing a thrust tube in a distal direction over the first and secondproximal portions of the cinching cord until the thrust tube reaches thedistal loop portion of the cinching cord and subsequently pressing thethrust tube in a distal direction while pulling the first and secondproximal portions of the cinching cord in a proximal direction.

In some embodiments of the first method, the fastening step comprisesfastening two portions of the cinching cord together using at least oneof a knot, a clamp, and a crimped fastener. In some embodiments of thefirst method, in the anchoring step, the distal loop portion of thecinching cord is anchored by anchoring the sleeve to at least one of theannulus and the tissue adjacent to the annulus using a plurality ofanchors.

In some embodiments of the first method, in the anchoring step, thedistal loop portion of the cinching cord is anchored by anchoring aplurality of anchors to at least one of the annulus and the tissueadjacent to the annulus, each of the anchors having an eyelet, whereinthe cinching cord passes through the eyelets in the anchors.

In some embodiments of the first method, the covering step comprisessliding an elongated cord protector having at least one lumen over thefirst and second proximal portions of the cinching cord so that thefirst and second proximal portions of the cinching cord pass through theat least one lumen. In some of these embodiments, the first methodfurther comprises removing the elongated cord protector subsequent tothe waiting step and prior to the cinching step.

Another aspect of the invention is directed to a sixth apparatus forpreventing tissue ingrowth from interfering with the operation of acinching cord that is implanted in a subject's body. The cinching cordhas a distal loop portion, a first proximal portion, and a secondproximal portion. The sixth apparatus comprises a flexible elongatedbody having a proximal end and a distal end. The elongated body has afirst lumen that runs between the proximal end and the distal end and asecond lumen that runs between the proximal end and the distal end. Thefirst lumen is dimensioned to slidably accommodate the first proximalportion of the cinching cord and the second lumen is dimensioned toslidably accommodate the second proximal portion of the cinching cord.The elongated body, the first lumen, and the second lumen are configuredto facilitate slidable installation of the elongated body over the firstand second proximal portions of the cinching cord such that theelongated body covers the first and second proximal portions of thecinching cord, with the first proximal portion of the cinching corddisposed in the first lumen and the second proximal portion of thecinching cord disposed in the second lumen. The elongated body preventstissue ingrowth into the elongated body, and the elongated body alsoprevents tissue ingrowth into the first and second proximal portions ofthe cinching cord when the elongated body covers the first and secondproximal portions of the cinching cord.

Some embodiments of the sixth apparatus further comprise a firstthreading cord that runs through the first lumen and extends distallybeyond the distal end of the elongated body, and a second threading cordthat runs through the second lumen and extends distally beyond thedistal end of the elongated body. Some of these embodiments furthercomprise a sterile envelope, and the elongated body, the first threadingcord that runs through the first lumen, and the second threading cordthat runs through the second lumen are all packaged inside the sterileenvelope.

In some embodiments of the sixth apparatus, the first threading cord isconfigured to draw the first proximal portion of the cinching cord intothe first lumen and the second threading cord is configured to draw thesecond proximal portion of the cinching cord into the second lumen, sothat the first and the second proximal portions of the cinching cord canoperate as a guidewires over which the elongated body can be slid into aposition at which the distal end of the elongated body is adjacent tothe distal loop portion of the cinching cord. In some of theseembodiments, the first threading cord extends proximally beyond theproximal end of the elongated body and the second threading cord extendsproximally beyond the proximal end of the elongated body.

In some embodiments of the sixth apparatus, the elongated body is formedfrom at least one of polyurethane and silicone. In some embodiments ofthe sixth apparatus, the elongated body has a length between 35 and 65cm and a diameter between 1 and 4 mm. In some embodiments of the sixthapparatus, the elongated body has a length between 45 and 55 cm. In someembodiments of the sixth apparatus, the elongated body has a diameterbetween 1.5 and 2.5 mm. In some embodiments of the sixth apparatus, theelongated body has a length between 45 and 55 cm and a diameter between1.5 and 2.5 mm. In some embodiments of the sixth apparatus, the firstlumen has a diameter between 0.2 and 1 mm and the second lumen has adiameter between 0.2 and 1 mm. In some embodiments of the sixthapparatus, the elongated body has a third lumen that is open at theproximal end, closed at the distal end, and extends through at leastthree-fourths of the elongated body, and the third lumen is dimensionedto slidably accommodate a stiffening wire. In some embodiments of thesixth apparatus, the elongated body has a third lumen that is open atthe proximal end, closed at the distal end, and extends through at leastthree-fourths of the elongated body, and the third lumen has a diameterbetween 0.2 and 1 mm. Some embodiments of the sixth apparatus furthercomprise a radio-opaque marker disposed near the distal end of theelongated body.

Some embodiments of the sixth apparatus further comprise a firstthreading cord that runs through the first lumen and extends distallybeyond the distal end of the elongated body, and a second threading cordthat runs through the second lumen and extends distally beyond thedistal end of the elongated body. In these embodiments, the firstthreading cord is configured to draw the first proximal portion of thecinching cord into the first lumen and the second threading cord isconfigured to draw the second proximal portion of the cinching cord intothe second lumen, so that the first and the second proximal portions ofthe cinching cord can operate as a guidewires over which the elongatedbody can be slid into a position at which the distal end of theelongated body is adjacent to the distal loop portion of the cinchingcord. In these embodiments, the elongated body is formed from at leastone of polyurethane and silicone, the elongated body has a lengthbetween 45 and 55 cm and a diameter between 1.5 and 2.5 mm, and thefirst lumen has a diameter between 0.2 and 1 mm and the second lumen hasa diameter between 0.2 and 1 mm. Some of these embodiments furthercomprise a radio-opaque marker disposed near the distal end of theelongated body. In some of these embodiments, the elongated body has athird lumen that is open at the proximal end, closed at the distal end,and extends through at least nine-tenths of the elongated body, and thethird lumen has a diameter between 0.2 and 1 mm.

Another aspect of the invention is directed to a seventh apparatus fordelivering an annulus ring or a cinching cord to the vicinity of anannulus. The seventh apparatus comprises an elongated core, at leastfour support arms, at least four anchor launchers, an inflatableballoon, and at least one retainer cord. The elongated core has a distalend. The support arms mounted to the core and extend distally beyond thedistal end of the core. Each of the anchor launchers has a distal end,and each of the anchor launchers is supported by a respective one of thesupport arms. The inflatable balloon is disposed between the between thesupport arms, configured so that when the balloon is inflated, theballoon will push the support arms away from each other. The at leastone retainer cord is connected to the support arms and arranged withrespect to the support arms to encompass the balloon and prevent theballoon from slipping out between the support arms.

In some embodiments of the seventh apparatus, the at least one retainercord comprises a single retainer cord that encompasses the balloon andprevents the balloon from slipping out between the support arms. In someof these embodiments, the single retainer cord is connected to thesupport arms using at least one knot. In some of these embodiments, thesingle retainer cord comprises at least one of silk, nylon,polypropylene, and polyester.

In some embodiments of the seventh apparatus, each of the support armsis enclosed in a sleeve, and the at least one retainer cord is connectedto the support arms by threading the at least one retainer cord througha hole in each of the sleeves. In some embodiments of the seventhapparatus, each of the support arms is enclosed in a sleeve, and the atleast one retainer cord is connected to the support arms by threadingthe at least one retainer cord through a hole in each of the sleeves andtying a knot at each of the sleeves. In some embodiments of the seventhapparatus, the at least one retainer cord comprises at least twosegments of cord that collectively encompass the balloon and prevent theballoon from slipping out between the support arms.

Some embodiments of the seventh apparatus further comprise a cinchingcord and at least four anchors, wherein each of the anchors is disposedin a respective one of the anchor launchers and connected to thecinching cord. In these embodiments, the support arms are configured tohold the distal ends of the anchor launchers at positions thatcorrespond to a shape of the annulus, with the distal ends of the anchorlaunchers distributed about a perimeter of the shape of the annulus.

Some embodiments of the seventh apparatus further comprises an annulusring and at least four anchors, wherein each of the anchors is disposedin a respective one of the anchor launchers and connected to the annulusring. In these embodiments, the support arms are configured to hold thedistal ends of the anchor launchers at positions that correspond to ashape of the annulus, with the distal ends of the anchor launchersdistributed about a perimeter of the shape of the annulus.

In some embodiments of the seventh apparatus, the at least four supportarms comprises at least eight support arms, and the at least four anchorlaunchers comprises at least eight anchor launchers.

Some embodiments of the seventh apparatus further comprise an outersleeve disposed around the core, the outer sleeve having a distal end.The outer sleeve is slidable with respect to the core between anextended position and a retracted position. When the outer sleeve is inthe extended position, the support arms, the anchor launchers, theballoon, and the at least one retainer cord are disposed within theouter sleeve. When the outer sleeve is in the retracted position, theanchor launchers, the at least one retainer cord, and at least a portionof the support arms extend distally beyond the distal end of the outersleeve.

Some embodiments of the seventh apparatus further comprise a firstsleeve disposed around the core, the first sleeve having a distalportion, wherein the first sleeve is slidable with respect to the corebetween an extended position and a retracted position; and a removablesecond sleeve slidably disposed around the distal portion of the firstsleeve. When the second sleeve is in an initial position, the supportarms, the anchor launchers, the balloon, and the at least one retainercord are disposed within the second sleeve. When the second sleeve isremoved and the first sleeve is in the retracted position, the anchorlaunchers are free to move to positions that correspond to the shape ofthe annulus.

Another aspect of the invention is directed to an eighth apparatus fordelivering an annulus ring or a cinching cord to the vicinity of anannulus. The eighth apparatus comprises an elongated core, at least foursupport arms, at least four anchor launchers, a shaft, an inflatableballoon, and at least one retainer cord. The elongated core has a distalend and a channel that runs through the core in a proximal-to-distaldirection. The support arms are mounted to the core and extend distallybeyond the distal end of the core. Each of the anchor launchers has adistal end, and each of the anchor launchers is supported by arespective one of the support arms. The shaft is slidably disposedwithin the channel, and the shaft has an inflation lumen. The inflatableballoon is mounted to the shaft and connected to the inflation lumen soas to permit inflation of the balloon via the inflation lumen. Theballoon is movable to a first position between the support arms byslidably adjusting a position of the shaft, and the balloon isconfigured so that when the balloon is inflated at the first position,the balloon will push the support arms away from each other. The atleast one retainer cord is connected to the support arms and arrangedwith respect to the support arms to, when the balloon is at the firstposition, encompass the balloon and prevent the balloon from slippingout between the support arms.

In some embodiments of the eighth apparatus, the balloon is movable to asecond position that is within the channel and proximal of the supportarms by slidably adjusting a position of the shaft. In some embodimentsof the eighth apparatus, the balloon is movable to a second positionthat is distally beyond the anchor launchers by slidably adjusting aposition of the shaft.

In some embodiments of the eighth apparatus, the at least one retainercord comprises a single retainer cord that encompasses the balloon andprevents the balloon from slipping out between the support arms. In thesome of these embodiments, the single retainer cord is connected to thesupport arms using at least one knot. In some of these embodiments, thesingle retainer cord comprises at least one of silk, nylon,polypropylene, and polyester.

In some embodiments of the eighth apparatus, each of the support arms isenclosed in a sleeve, and the at least one retainer cord is connected tothe support arms by threading the at least one retainer cord through ahole in each of the sleeves. In some embodiments of the eighthapparatus, each of the support arms is enclosed in a sleeve, and the atleast one retainer cord is connected to the support arms by threadingthe at least one retainer cord through a hole in each of the sleeves andtying a knot at each of the sleeves. In some embodiments of the eighthapparatus, the at least one retainer cord comprises at least twosegments of cord that collectively encompass the balloon and prevent theballoon from slipping out between the support arms.

Some embodiments of the eighth apparatus further comprise a cinchingcord and at least four anchors, wherein each of the anchors is disposedin a respective one of the anchor launchers and connected to thecinching cord. In these embodiments, the support arms are configured tohold the distal ends of the anchor launchers at positions thatcorrespond to a shape of the annulus, with the distal ends of the anchorlaunchers distributed about a perimeter of the shape of the annulus.

Some embodiments of the eighth apparatus further comprise an annulusring and at least four anchors, wherein each of the anchors is disposedin a respective one of the anchor launchers and connected to the annulusring. In these embodiments, the support arms are configured to hold thedistal ends of the anchor launchers at positions that correspond to ashape of the annulus, with the distal ends of the anchor launchersdistributed about a perimeter of the shape of the annulus.

In some embodiments of the eighth apparatus, the at least four supportarms comprises at least eight support arms, the at least four anchorlaunchers comprises at least eight anchor launchers.

Some embodiments of the eighth apparatus further comprise an outersleeve disposed around the core, the outer sleeve having a distal end.The outer sleeve is slidable with respect to the core between anextended position and a retracted position. When the outer sleeve is inthe extended position, the support arms, the anchor launchers, theballoon, and the at least one retainer cord are disposed within theouter sleeve. When the outer sleeve is in the retracted position, theanchor launchers, the at least one retainer cord, and at least a portionof the support arms extend distally beyond the distal end of the outersleeve.

Some embodiments of the eighth apparatus further comprise a first sleevedisposed around the core, the first sleeve having a distal portion,wherein the first sleeve is slidable with respect to the core between anextended position and a retracted position; and a removable secondsleeve slidably disposed around the distal portion of the first sleeve.When the second sleeve is in an initial position, the support arms, theanchor launchers, the balloon, and the at least one retainer cord aredisposed within the second sleeve. When the second sleeve is removed andthe first sleeve is in the retracted position, the anchor launchers arefree to move to positions that correspond to the shape of the annulus.

Another aspect of the invention is directed to a ninth apparatus fordelivering an annulus ring or a cinching cord to the vicinity of anannulus. The ninth apparatus comprises an elongated core, at least foursupport arms, at least four anchor launchers, a first shaft, aninflatable first balloon, a nosecone, a second shaft, and an inflatablesecond balloon. The elongated core has a distal end and a channel thatruns through the core in a proximal-to-distal direction. The supportarms are mounted to the core and extend distally beyond the distal endof the core. Each of the anchor launchers has a distal end, and each ofthe anchor launchers is supported by a respective one of the supportarms. The first shaft is disposed within the channel, and the firstshaft has a first inflation lumen. The inflatable first balloon ismounted to the first shaft and connected to the first inflation lumen soas to permit inflation of the first balloon via the first inflationlumen, and the first balloon is configured so that when the firstballoon is inflated at a first position, the first balloon will push thesupport arms away from each other. The second shaft is slidably disposedwithin the channel, and the second shaft has a second inflation lumen.The inflatable second balloon is mounted to the second shaft andconnected to the second inflation lumen so as to permit inflation of thesecond balloon via the second inflation lumen, and the second balloon isdisposed distally beyond the first balloon.

In some embodiments of the ninth apparatus, the first shaft is slidablydisposed within the channel, and the first balloon is movable to thefirst position by slidably adjusting a position of the first shaft. Insome of these embodiments, the first balloon is movable to a secondposition that is within the channel and proximal of the support arms byslidably adjusting a position of the first shaft.

Some embodiments of the ninth apparatus further comprise an outer sleevedisposed around the core, the outer sleeve having a distal end. Theouter sleeve is slidable with respect to the core between an extendedposition and a retracted position. When the outer sleeve is in theextended position, the support arms, the anchor launchers, and the firstballoon are disposed within the outer sleeve. When the outer sleeve isin the retracted position, the anchor launchers and at least a portionof the support arms extend distally beyond the distal end of the outersleeve. Some of these embodiments further comprise a nosecone that ismovable between a proximal position and a distal position, such thatwhen the nosecone is in the proximal position and the outer sleeve is inthe extended position, the nosecone is disposed at the distal end of theouter sleeve.

In some embodiments of the ninth apparatus that include a nosecone, thesecond shaft extends distally beyond the nosecone and the second balloonis located distally beyond the nosecone. In some embodiments of theninth apparatus, the nosecone is mounted to the second shaft, and thenosecone is movable between the proximal position and the distalposition by slidably adjusting a position of the second shaft.

In some embodiments of the ninth apparatus that include a nosecone, thefirst shaft is slidably disposed within the channel, and first balloonis movable to the first position by slidably adjusting a position of thefirst shaft. The second shaft extends distally beyond the nosecone andthe second balloon is located distally beyond the nosecone. The noseconeis mounted to the second shaft, and the nosecone is movable between theproximal position and the distal position by slidably adjusting aposition of the second shaft.

Some embodiments of the ninth apparatus that include a nosecone furthercomprise a third shaft slidably disposed within the channel. In theseembodiments, the nosecone is mounted to the third shaft, and thenosecone is movable between the proximal position and the distalposition by slidably adjusting a position of the third shaft. In someembodiments of the ninth apparatus, the nosecone is located distallybeyond the second balloon.

Some embodiments of the ninth apparatus further comprise a cinching cordand at least four anchors. In these embodiments, each of the anchors isdisposed in a respective one of the anchor launchers and connected tothe cinching cord. The support arms are configured to hold the distalends of the anchor launchers at positions that correspond to a shape ofthe annulus, with the distal ends of the anchor launchers distributedabout a perimeter of the shape of the annulus.

Some embodiments of the ninth apparatus further comprise an annulus ringand at least four anchors, wherein each of the anchors is disposed in arespective one of the anchor launchers and connected to the annulusring. In these embodiments, the support arms are configured to hold thedistal ends of the anchor launchers at positions that correspond to ashape of the annulus, with the distal ends of the anchor launchersdistributed about a perimeter of the shape of the annulus.

In some embodiments of the ninth apparatus, the at least four supportarms comprises at least eight support arms, and the at least four anchorlaunchers comprises at least eight anchor launchers. In some embodimentsof the ninth apparatus, the annulus is a mitral valve annulus. In otherembodiments of the ninth apparatus, the annulus is a tricuspid valveannulus.

Another aspect of the invention is directed to a second method forimplanting an annulus ring or a cinching cord to a heart valve annulusor into tissue adjacent to the annulus. The annulus is disposed betweenan atrium and a ventricle of the heart and the heart has an apex. Thesecond method comprises delivering an assembly into the atrium, whereinthe assembly includes (a) the annulus ring or the cinching cord, (b) aplurality of anchors connected to the annulus ring or the cinching cord,and (c) a plurality of anchor launchers configured to launch the anchorsinto the annulus or into the tissue adjacent to the annulus. Theassembly is supported by a supporting member. The second method alsocomprises positioning the assembly such that the annulus ring or thecinching cord is adjacent to the annulus or the tissue adjacent to theannulus on the atrium side of the annulus. The second method alsocomprises advancing an inflatable balloon into the ventricle, whereinthe balloon is supported by the supporting member, and inflating theballoon while the balloon is in the ventricle. The second method alsocomprises adjusting a position of the balloon within the ventricle sothat when a selected portion of the cardiac cycle occurs while theballoon is inflated, forces on the balloon will urge the balloon towardthe apex of the heart, which will urge the supporting member toward theapex of the heart, which will urge the annulus ring or the cinching cordtowards the annulus or towards the tissue adjacent to the annulus. Thesecond method also comprises determining a time when the selectedportion of the cardiac cycle is occurring while the inflated balloon isat the adjusted position, and triggering the anchor launchers so thatthe anchor launchers launch the anchors into the annulus or into thetissue adjacent to the annulus during the selected portion of thecardiac cycle while the inflated balloon is at the adjusted position.

In some embodiments of the second method, the determining comprisesdetecting when the supporting member is being pulled in a distaldirection. In some embodiments of the second method, the advancingcomprises sliding a shaft to which the inflatable balloon is mounted ina distal direction with respect to the supporting member. In someembodiments of the second method, the positioning comprises inflating anadditional balloon between a plurality of support arms that support theanchor launchers so that the additional balloon pushes the support armsaway from each other.

In some embodiments of the second method, the delivering comprises (a)introducing the annulus ring or the cinching cord, the anchors, and theanchor launchers into the atrium while the cinching cord, the anchors,and the anchor launchers are collapsed within an outer sleeve; and (b)retracting the outer sleeve so that the cinching cord, the anchors, andthe anchor launchers extend beyond a distal end of the outer sleeve. Insome embodiments of the second method, the valve annulus is a mitralvalve annulus. In some embodiments of the second method, the valveannulus is a tricuspid valve annulus.

Another aspect of the invention is directed to a third method forimplanting an annulus ring or a cinching cord to a tricuspid valveannulus or into tissue adjacent to the annulus. The third methodcomprises delivering an assembly into a right atrium, wherein theassembly includes (a) the annulus ring or the cinching cord, (b) aplurality of anchors connected to the annulus ring or the cinching cord,and (c) a plurality of anchor launchers configured to launch the anchorsinto the annulus or into the tissue adjacent to the annulus, wherein theassembly is supported by a supporting member. The third method alsocomprises positioning the assembly such that the annulus ring or thecinching cord is adjacent to the annulus or the tissue adjacent to theannulus on the right atrium side of the annulus, and advancing aninflatable balloon in a deflated state into a pulmonary artery. Theballoon is supported by the supporting member. The third method alsocomprises inflating the balloon while the balloon is in the pulmonaryartery, so as to anchor the balloon at a location, and adjusting aposition of the assembly while the balloon remains anchored at thelocation so as to press the annulus ring or the cinching cord towardsthe annulus or towards the tissue adjacent to the annulus. The thirdmethod also comprises launching the anchors into the annulus or into thetissue adjacent to the annulus after the adjusting, deflating theballoon, and withdrawing the assembly.

In some embodiments of the third method, the pulmonary artery is a rightpulmonary artery.

In some embodiments of the third method, the pulmonary artery is a leftpulmonary artery.

In some embodiments of the third method, the advancing comprises slidinga shaft to which the inflatable balloon is mounted in a distal directionwith respect to the supporting member.

In some embodiments of the third method, the positioning comprisesinflating an additional balloon between a plurality of support arms thatsupport the anchor launchers so that the additional balloon pushes thesupport arms away from each other.

In some embodiments of the third method, the delivering comprisesintroducing the annulus ring or the cinching cord, the anchors, and theanchor launchers into the right atrium while the cinching cord, theanchors, and the anchor launchers are collapsed within an outer sleeve.

Another aspect of the invention is directed to a tenth apparatus forinstalling a cinching cord onto an annulus or onto tissue adjacent tothe annulus. This apparatus comprises a housing, an elongated core, acinching cord, at least four support arms, at least four anchors, atleast four anchor launchers, at least one wire, and a pushing member.The elongated core is mounted with respect to the housing. The core has(a) a distal end, (b) at least one second channel that runs through thecore in a proximal-to-distal direction, and (c) at least one fourthchannel that runs through the core in a proximal-to-distal direction.The cinching cord has a distal loop portion, a first proximal portion,and a second proximal portion, wherein the first proximal portion of thecinching cord is slidably disposed within the at least one secondchannel and extends distally beyond the distal end of the core, andwherein the second proximal portion of the cinching cord is slidablydisposed within the at least one second channel and extends distallybeyond the distal end of the core. The support arms are mounted to thecore and extend distally beyond the distal end of the core. The anchorsare configured to anchor the distal loop portion of the cinching cordinto the annulus or into the tissue adjacent to the annulus. Each of theanchor launchers is supported by a respective one of the support arms,and each of the anchor launchers is configured to launch a respectiveone of the anchors into the annulus or into the tissue adjacent to theannulus. The at least one wire (i) is slidably disposed within the atleast one fourth channel, (ii) has a distal end that extends distallybeyond the distal end of the core, and (iii) has a proximal end thatextends proximally beyond the fourth channel. The pushing member isaffixed to the distal end of the at least one wire such that pushing theproximal end of the at least one wire in a distal direction will pushthe pushing member in a distal direction. The cinching cord and the atleast one second channel are configured so that after the distal loopportion of the cinching cord is anchored to the annulus or into thetissue adjacent to the annulus by the at least four anchors, progressivemovement of the housing in a proximal direction will cause the core toprogressively move in a proximal direction with respect to the first andsecond proximal portions of the cinching cord. The pushing member isconfigured so that after the distal loop portion of the cinching cord isanchored to the annulus or into the tissue adjacent to the annulus bythe at least four anchors, pushing the pushing member in a distaldirection will hinder dislodgement of the anchors during the movement ofthe housing in the proximal direction.

In some embodiments of the tenth apparatus, the distal loop portion ofthe cinching cord is covered by a sleeve that promotes tissue ingrowth.

In some embodiments of the tenth apparatus, the pushing member has atleast one passage, and the first proximal portion and the secondproximal portion of the cinching cord are slidably disposed in the atleast one passage.

In some embodiments of the tenth apparatus, the pushing member has adistal end and a proximal end, and at least one passage that passesthrough the pushing member in a proximal to distal direction, and thefirst proximal portion and the second proximal portion of the cinchingcord are slidably disposed in the at least one passage.

In some embodiments of the tenth apparatus, the pushing member comprisesa hollow cylinder aligned so that an axial axis of the hollow cylinderis parallel to the at least one wire, and the first proximal portion andthe second proximal portion of the cinching cord are slidably disposedwithin the hollow cylinder.

In some embodiments of the tenth apparatus, the at least one secondchannel comprises a plurality of lumens, and each of the first proximalportion of the cinching cord and the second proximal portion of thecinching cord is slidably disposed within a respective one of theplurality of lumens. In some of these embodiments, the at least one wirecomprises a plurality of wires, the at least one fourth channelcomprises a plurality of channels, and each of the plurality of wires isslidably disposed within a respective one of the plurality of channels.

In some embodiments of the tenth apparatus, the pushing member isconfigured so that after the distal loop portion of the cinching cord isanchored to the annulus or into the tissue adjacent to the annulus bythe at least four anchors, pushing the pushing member in a distaldirection will press the cinching cord against the annulus or the tissueadjacent to the annulus.

Some embodiments of the tenth apparatus further comprise at least onecrush-resistant channel disposed distally beyond the distal end of thecore, wherein the first and second proximal portions of the cinchingcord are slidably disposed within the at least one crush-resistantchannel. In some of these embodiments, before the distal loop portion ofthe cinching cord is anchored to the annulus or into the tissue adjacentto the annulus by the at least four anchors, the at least onecrush-resistant channel extends to the pushing member. In some of theseembodiments, the at least one crush-resistant channel is supported by atleast one support arm that is affixed to the core.

In some embodiments of the tenth apparatus, the at least one secondchannel comprises a plurality of lumens, and each of the first proximalportion of the cinching cord and the second proximal portion of thecinching cord is slidably disposed within a respective one of theplurality of lumens. The at least one wire comprises a plurality ofwires, the at least one fourth channel comprises a plurality ofchannels, and each of the plurality of wires is slidably disposed withina respective one of the plurality of channels. The pushing member isconfigured so that after the distal loop portion of the cinching cord isanchored to the annulus or into the tissue adjacent to the annulus bythe at least four anchors, pushing the pushing member in a distaldirection will press the cinching cord against the annulus or the tissueadjacent to the annulus. In some of these embodiments, the pushingmember has a distal end and a proximal end, and at least one passagethat passes through the pushing member in a proximal to distaldirection. The first proximal portion and the second proximal portion ofthe cinching cord are slidably disposed in the at least one passage.

Another aspect of the invention is directed to a fourth method ofattaching a cinching cord with a distal loop portion to an annulus or totissue adjacent to the annulus. The fourth method comprises deliveringthe distal loop portion of the cinching cord to a vicinity of theannulus using a percutaneous delivery tool, and launching at least fouranchors into the annulus or into the tissue adjacent to the annulus. Theat least four anchors are configured to affix the distal loop portion ofthe cinching cord to the annulus or to the tissue adjacent to theannulus. The fourth method also comprises withdrawing the percutaneousdelivery tool in a proximal direction after the at least four anchorshave been launched, and pressing a pushing member in a distal directionso that the pushing member holds a portion of the cinching cord againstthe annulus or against the tissue adjacent to the annulus with enoughpressure to prevent dislodgment of any of the at least four anchorsduring the withdrawal of the percutaneous delivery tool.

In some embodiments of the fourth method, the at least four anchorscomprises at least eight anchors.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are left and right side views, respectively, of anembodiment of an apparatus for installing a cinching cord or an annulusring onto a cardiac valve annulus when the outer sleeve is in anextended position.

FIGS. 2A and 2B are left and right side views, respectively, of the FIG.1 embodiment as it appears when the outer sleeve in a retractedposition.

FIG. 3 is a detailed view of the distal end of the FIG. 1 embodimentwhen the outer sleeve is in the extended position.

FIG. 4A is a detailed view of the core in the FIG. 3 embodiment.

FIG. 4B depicts how the support arms are affixed to the core in the FIG.3 embodiment.

FIGS. 5A, 5B, and 5C depict respective views of the portion of the FIG.1 embodiment that moves the outer sleeve between the extended positionand the retracted position.

FIG. 6A is a detailed view of a distal assembly that has emerged fromwithin the outer sleeve in the FIG. 1 embodiment.

FIG. 6B depicts the FIG. 6A view with additional sleeves that covercertain components.

FIG. 7A depicts the FIG. 3 apparatus after the distal end of theapparatus has been inserted into the left atrium and the outer sleevehas been partially retracted.

FIG. 7B depicts the FIG. 3 apparatus after the outer sleeve has beenfully retracted.

FIG. 7C depicts the FIG. 3 apparatus after the balloon has beeninflated.

FIG. 7D depicts the FIG. 3 apparatus immediately after the anchors havebeen launched into the annulus.

FIG. 8A depicts the FIG. 3 apparatus after the balloon is deflated andcertain components have been pulled partially back into the outersleeve.

FIG. 8B depicts the FIG. 3 apparatus after those components have beenpulled further back into the outer sleeve.

FIG. 9A is a detail of the proximal portion of FIG. 5A.

FIG. 9B is a detail cutaway view of the center portion of FIG. 9A.

FIG. 10A depicts a cord protector for preventing tissue ingrowth

FIG. 10B depicts the cord protector of FIG. 10A combined with a set ofthreading cords.

FIG. 11 is a flowchart of a method for preventing tissue ingrowth frominterfering with the cinching of an annulus.

FIG. 12A depicts a cord protector while it is being slid in a distaldirection over the proximal portions of the cinching cord.

FIG. 12B depicts the cord protector of FIG. 12A after reaching thedistal loop portion of the cinching cord.

FIG. 13A depicts the cinching cord of FIG. 12A after the cord protectorhas been withdrawn.

FIG. 13B depicts the cinching cord of FIG. 12A after a thrust tube hasslid over the proximal portions of the cinching cord and reached thedistal loop portion of the cinching cord.

FIG. 14 depicts a variation of the FIG. 3 embodiment that has anadditional balloon.

FIG. 15 is a flowchart of a method for using the FIG. 14 embodiment.

FIG. 16 depicts a variation of the FIG. 6A embodiment in which thecinching cord has been replaced by an annulus ring.

FIG. 17 depicts another embodiment of an apparatus for installing acinching cord that reduces the risk of dislodgment.

FIG. 18 depicts the FIG. 17 embodiment after the anchors have beenimplanted and withdrawal of the apparatus has begun.

FIG. 19 depicts another embodiment that is similar to the FIG. 14embodiment but uses a two-part sleeve and omits the nosecone.

Various embodiments are described in detail below with reference to theaccompanying drawings, wherein like reference numerals represent likeelements.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

This application describes methods and apparatuses for delivering andinstalling a cinching cord or an annulus ring into a cardiac valveannulus. In the cinching cord embodiments, once a cinching cord isinstalled into a cardiac valve annulus using the apparatuses and/ormethods described herein, and after waiting for tissue ingrowth tooccur, the cinching cord can be cinched in order to reduce the diameterof the annulus. These embodiments are useful for correcting or improvinga variety of valve-related conditions (including but not limited tomitral valve regurgitation). In the annulus ring embodiments, an annulusring is installed into a cardiac valve annulus to either (a) stabilizethe shape of the annulus and prevent the annulus from expanding or (b)serve as the foundation onto which a replacement valve can be mounted.These embodiments are useful in the contexts of reducing valveregurgitation and cardiac valve replacement.

FIGS. 1A, 1B, 2A, and 2B are views of an apparatus 25 for delivering andinstalling a cinching cord or an annulus ring onto a cardiac valveannulus, such as the mitral valve annulus or the tricuspid valveannulus. In all four of these figures, the housing 40 is disposed on theproximal side of the apparatus 25, and the outer sleeve 60 is disposedat the distal side of the apparatus. More specifically, FIGS. 1A and 1Bare left and right side views, respectively, of the apparatus 25 as itappears when the outer sleeve 60 of the apparatus is in an extendedposition; and FIGS. 2A and 2B are left and right side views,respectively, of the same apparatus 25 as it appears when the outersleeve 60 is in a retracted position. When the outer sleeve 60 isretracted (as shown in FIGS. 2A and 2B), the distal assembly 70 (whichincludes the distal loop portion of the cinching cord or the annulusring) extends out past the distal end of the outer sleeve 60. When theouter sleeve 60 is extended (as shown in FIGS. 1A and 1B), the distalassembly is collapsed and is disposed within the outer sleeve 60, and istherefore not visible in those figures. The extension and retraction ofthe outer sleeve 60 with respect to the core 50 is controlled by thesleeve retractor 44, which is described below.

FIG. 3 is a detailed view of the distal end of the apparatus 25 of FIG.1 when the outer sleeve 60 is in its extended position. In this figure,the various components that make up the distal assembly 70 (shown inFIG. 2A) are all collapsed and contained within the outer sleeve 60. Apreferred length of the outer sleeve 60 is 50 cm. In some embodiments,the outer diameter of the outer sleeve 60 is 22 French. Note that inalternative embodiments (e.g., the FIG. 17/18 embodiment discussedbelow), the one-piece outer sleeve 60 may be replaced with a pluralityof sleeves.

The outer sleeve 60 is disposed around an elongated core 50, such thatthe outer sleeve is slidable with respect to the core between theextended position and the retracted position. In some embodiments, thecore 50 is made of a flexible and noncompressible polymer. In someembodiments, the outer diameter of the core 50 is 5.7 mm. In alternativeembodiments, the outer diameter of the core is between 5.0 and 6.5 mm.The gap between the outer surface of the core 50 and the inner diameterof the outer sleeve 60 is dimensioned to facilitates the slidablerelationship between the outer sleeve 60 and the core 50. A main channel55 runs through the center of the core 50. In some embodiments, thediameter of this main channel 55 is 3.7 mm. In alternative embodiments,this diameter can vary between 3.0 and 4.5 mm.

At least four support arms 72 are mounted to the core 50. The supportarms 72 extend distally beyond the distal end of the core. Suitablematerials for forming the support arms 70 to include stainless steel,nitinol, and other biocompatible metals. The support arms are flexibleenough to collapse within the outer sleeve 60, but spring back to theiroriginal shape when extended distally beyond the confines of the outersleeve 60.

At least four anchor launchers 74 are supported by respective ones ofthe at least four support arms 72. Each of the anchor launchers has adistal end. Suitable designs for the anchor launchers and the anchorscontained therein can be found in U.S. application Ser. Nos. 14/895,711and 15/163,453, each of which is incorporated herein by reference. Ananchor is disposed in each of the anchor launchers 74. Each of theanchor launchers 74 is has a pull-wire trigger, and each of the pullwires 76 is operatively connected to one of the anchor launchers 74 sothat pulling on a respective pull wire will launch the respectiveanchor.

Note that while FIG. 3 depicts four support arms 72 and four anchorlaunchers 74, it is more preferable to use at least eight support arms72 and at least eight anchor launchers 74 (e.g. between 8 and 16 supportarms and between 8 and 16 anchor launchers). But only four support armsand anchor launchers are depicted in FIG. 3 to make those componentseasier to see.

A cinching cord has a distal loop portion, a first proximal portion 84,and a second proximal portion 84. The distal loop portion 82 (shown inFIG. 6A) of the cinching cord is preferably surrounded by a sleeve 86 ofmaterial that promotes tissue ingrowth. The sleeve 86 is preferably softand flexible. Suitable materials include a fabric braids (e.g., made ofpolyethylene terephthalate (PET) fabric. The anchors that are disposedwithin the anchor launchers 74 are connected to the distal loop portion82 of the cinching cord. In some embodiments, this connection isimplemented by connecting the anchors directly to the distal loopportion 82 of the cinching cord. In alternative embodiments, thisconnection is implemented by connecting the anchors to the sleeve 86that surrounds the distal loop portion 82 of the cinching cord.

A shaft 106 is disposed within the main channel 55 and the shaft 106 hasan inflation lumen. An inflatable balloon 105 is mounted to the shaft106 and connected to the inflation lumen so as to permit inflation ofthe balloon 105 via the inflation lumen. The balloon 105 is configuredso that when the outer sleeve 60 is retracted and the balloon 105 isinflated when disposed at a first position located between the supportarms 72 (as best seen in FIGS. 7B and 7C), the balloon 105 will push thesupport arms 72 away from each other to help move the support arms 72into positions at which the support arms 72 hold the distal ends of theanchor launchers 74 at positions that correspond to the shape of theannulus, with the distal ends of the anchor launchers 74 distributedabout the perimeter of the shape of the annulus.

Note that even without the balloon 105, the support arms 72 are shapedto hold the distal ends of the anchor launchers 74 at positions thatcorrespond to the shape of the annulus. But because the support arms 72may become entangled with each other while they are collapsed within theouter sleeve 60, the balloon 105 is useful for untangling the supportarms. In addition, the balloon 105 stiffens the structure formed by thesupport arms 72 and the distal loop portion 82 of the cinching cord soit becomes a relatively rigid structure that, in some preferredembodiments, fits very closely into the shape of the atrium.

Preferably, the shaft 106 is slidably disposed within the main channel55, and the balloon 105 is movable to the first position by slidablyadjusting a position of the shaft 106. Optionally, the balloon 105 maybe movable to a second position that is within the main channel 55 andproximal of the support arms 72 by slidably adjusting a position of theshaft 106.

This embodiment also includes a nosecone 100 that is movable between aproximal position and a distal position. When the nosecone 100 is in theproximal position and the outer sleeve 60 is in the extended position,the nosecone 100 is disposed at the distal end of the outer sleeve 60,as seen in FIG. 3.

In some embodiments, the nosecone 100 is mounted to a nosecone shaft101, and the nosecone is movable between the proximal position and adistal position by slidably adjusting a position of the nosecone shaft101. FIG. 7A-D show the nosecone 100 when it is positioned at the distalposition. In alternative embodiments, the nosecone is omitted entirely.

FIG. 4A is a detailed view of the core 50 from the FIG. 3 embodiment.The core 50 has a distal end and a main channel 55 that runs through thecore in a proximal-to-distal direction, and is centered about the radialcenter of the core 50. The core 50 also has at least four first channels51 that run through the core in a proximal-to-distal direction, and eachof the first channels 51 is dimensioned to accommodate a respective oneof the pull wires 76. Preferably, each of the first channels 51 is alumen. In some embodiments, the walls of these lumens 51 are made fromthe same material as the core 50. In alternative embodiments, the wallsof these lumens 51 are lined with a smooth material such as PTFE.

The core 50 also has at least one second channel 52 that runs throughthe core in a proximal-to-distal direction, and the at least one secondchannel 52 is dimensioned to accommodate the first and second proximalportions 84 of the cinching cord. Preferably, each of the proximalportions 84 of the cinching cord runs through its own individual secondchannel 52, and each of these second channels is dimensioned toaccommodate a respective proximal portion 84 of the cinching cord.However, in less preferred embodiments, both the first and secondproximal portions 84 of the cinching cord can run through a singlesecond channel 52. Preferably, each of the second channels 52 is alumen. In some embodiments, the walls of these lumens 52 are made fromthe same material as the core 50. In alternative embodiments, the wallsof these lumens 52 are lined with a smooth material such as PTFE.

Preferably, each of the first channels 51 and each of the at least onesecond channel 52 is located at positions that are radially beyond themain channel 55. Optionally, each of the first channels 51 and each ofthe at least one second channel 52 is located at the same radialdistance from the radial center of the core 50.

The core 50 also has a plurality of third channels 53 that run throughthe core in a proximal-to-distal direction, and the plurality of thirdchannels 53 are dimensioned to accommodate the support rods 95 describedbelow in connection with FIG. 4B. In some preferred embodiments, thediameter of each of the first channels 51, each of the second channels52, and each of the third channels 53 is 0.45 mm.

FIG. 4B depicts one preferred approach for mounting the support arms 72to the core 50. In this approach, the support arms 72 are affixed to aplurality of support rings 90, and the support arms extend in a distaldirection from the support rings. A plurality of support rods 95 arealso affixed to the support rings, and the support rods extend in aproximal direction from the support rings. These support rods 95 may beformed of metal wire. Using this subassembly (which includes the supportrings 90, the support rods 95, and the support arms 72), the supportarms 72 can be mounted to the core 50 by inserting the support rods 95into the third channels 53 of the core 50, so as to yield theconfiguration depicted in FIG. 3.

The support rings 90 each have a plurality of holes 92, and these holes92 are positioned so that when the support rods 95 have been insertedinto the third channels 53 of the core 50, the holes 92 in the supportrings will line up with the first channels 51 and the second channels 52in the core 50. The support rings 90 also include at least four cut outs93 dimensioned and configured to support the support arms 72 and aplurality of cut outs 94 dimensioned and configured to support thesupport rods 95.

Optionally, radio-opaque material (e.g. 80% platinum and 20% iridium, orother alternatives that will be apparent to persons skilled in therelevant arts) may be added to the subassembly to help ascertain theposition of the apparatus during the procedure for installing thecinching cord or annulus ring using fluoroscopy. Preferably, theradio-opaque material is distributed in an asymmetric pattern. Forexample, a pair of radio-opaque sleeves 98 may be disposed on one of thesupport arms 95, and a single radio-opaque sleeve 98 may be disposed onanother one of the support arms 95. Using an asymmetric distribution ofradio-opaque material makes it easier to ascertain the orientation ofthe apparatus during the procedure for installing the cinching cord orannulus ring, because different portions of the apparatus will lookdifferent under fluoroscopy. Of course, it will be appreciated bypersons skilled in the relevant art that the radio-opaque material maybe distributed in a wide variety of different asymmetric patterns, andstill remain useful for positioning and orientation purposes.

Returning to FIG. 3, the first and second proximal portions 84 of thecinching cord are disposed in the at least one second channel 52 and canslide easily within the at least one second channel 52. In addition,each of the at least four pull wires 76 is disposed in a respective oneof the first channels 51 and can slide easily within the first channels51.

When the outer sleeve 60 is in the extended position (as it is in FIG.3), the support arms 72 and the anchor launchers 74 are disposed withinthe outer sleeve 60. But when the outer sleeve 60 is in the retractedposition, the anchor launchers 74 and at least a portion of the supportarms 72 extend distally beyond the distal end of the outer sleeve 60 (asbest seen in FIGS. 6A and 6B).

FIGS. 5A-C depict the portion of the apparatus 25 that moves the outersleeve 60 between the extended position (as depicted in FIGS. 1 and 3)and the retracted position (as depicted in FIGS. 2 and 6). Componentswith similar numbers correspond to the same components discussed abovein connection with FIGS. 1-4.

The apparatus 25 includes a housing 40 that is sized to be held in aperson's hand and it has a plurality of controls 44 a, 47 that are usedto operate the apparatus 25. The housing may be formed of thermoplastic,metal, or any other suitable material. The elongated core 50 is mountedin a fixed spatial relationship with respect to the housing 40, and themounting of the core 50 to the housing 40 may be implemented eitherdirectly or via intermediate components. The outer sleeve 60 (shown inFIGS. 3 and 5A) is disposed around the core 50 and the outer sleeve 60is slidable with respect to the core 50 between an extended position anda retracted position.

In the illustrated embodiment, the sleeve retractor 44 is responsiblefor moving the outer sleeve 60 with respect to the core 50. This isaccomplished using a rack-and-pinion that includes rack 44 r and pinion44 p. A steering control assembly 42 (that preferably facilitates medialand anterior deflecting of the catheter shaft and also rotation withrespect to the housing 40) is affixed to the distal end of the rack 44r, and the outer sleeve 60 is affixed to the distal end of the steeringcontrol assembly 42. As a result, the outer sleeve 60 will track themovements of the rack 44 r. Clockwise rotation of the actuator 44 a willcause the pinion 44 p to rotate in a clockwise direction, which willcause the rack 44 r to move in a proximal direction with respect to thehousing 40. Preferably, a locking pin 44 k prevents the rack 44 r frommoving when the locking pin 44 k is inserted, which preventsunintentional retraction of the outer sleeve 60 during insertion of theapparatus.

Because of the core 50 is in a fixed spatial relationship with respectto the housing, movement of the rack 44 r in the proximal direction willcause the outer sleeve 60 to slide in a proximal direction with respectto the core 50. This will cause the outer sleeve 60 to move from theextended position (shown in FIGS. 1 and 3) to the retracted positionshown in FIGS. 2 and 6A.

FIG. 6A is a detailed view of a distal assembly 70 that has emerged fromwithin the outer sleeve 60 as a result of the retraction of the outersleeve 60, so that the distal assembly 70 extends distally beyond thedistal end of the outer sleeve 60. The distal assembly 70 in thisembodiment includes ten anchor launchers 74, each of which is supportedby its own individual support arm 72. In some embodiments, the supportarms 72 are mounted to the core 50 as described above in connection withFIGS. 3-4. The support arms are shaped such that when the outer sleeve60 is in the retracted position, the support arms 72 hold the distalends of the anchor launchers 74 at positions that correspond to a shapeof the annulus, with the distal ends of the anchor launchers 74distributed about a perimeter of the shape of the annulus (see also FIG.7C).

Note that the shape of the distal loop portion 82 of the cinching cordin FIG. 6A is round, and this shape is suitable when the cinching cordis installed onto a round annulus. In alternative embodiments, when thecinching cord is installed onto an annulus with a different shape (e.g.,a mitral valve annulus that is D-shaped), the support arms 72 arepre-shaped so that the distal ends of the anchor launchers 74 will bedistributed about the perimeter of that differently-shaped annulus.

Preferably, the shape and size of the support arms 72 are designed tofit the anatomy of the individual patient, so that when the outer sleeve60 is retracted, the distal loop portion 82 of the cinching cord will beopened by the support arms 72 and spread around the annulus, so that itwill be in the correct location ready for the anchors to be launchedwith little adjustment. This may be achieved, e.g., by designing the 3Dshape of the support arms 72 so that they each extend in a predefinedangulation from the core 50.

The desired shape of the support arms 72 and the circumference of thedistal loop portion 82 of the cinching cord may be determined byconverting a CT scan of the patient into a 3D CAD file. The support arms72 can then be formed so that they will hold the distal loop portion 82of the cinching cord in a configuration that matches the target annulus.One preferred approach for accomplishing this is to insert the anchorlaunchers 74 into a jig that holds the distal ends of the anchorlaunchers 74 at positions that match the annulus in the CAD file. Anassembly that includes the support rings 90, the support rods 95 and thesupport arms 72 is then attached to the anchor launchers 74 (e.g. usingwelding or an appropriate adhesive). The jig will also hold the supportrods 95 at a position that provides an appropriate angle between thesupport rods 95 and the support arms 72. The assembly (with the anchorlaunchers 74 attached) is then heated to take on the shape that is beingforced upon it by the jig. Optionally, the support arms may be made of ashape-memory material e.g. nitinol.

A cinching cord has a distal loop portion 82, a first proximal portion84, and a second proximal portion 84. The distal loop portion 82 of thecinching cord is preferably surrounded by a sleeve 86 of material thatpromotes tissue ingrowth such as a fabric braid. As explained above, theanchors that are disposed within the anchor launchers 74 are connectedto the distal loop portion 82 of the cinching cord, and the anchorlaunchers 74 are configured so that pulling on a respective pull wire 76will launch the respective anchor.

FIG. 6B is similar to FIG. 6A (and similar reference numbers correspondto similar features), except that FIG. 6B also shows a set of sleeves79, 89 that were omitted from FIG. 6A for clarity. Each of the anchorlaunchers 74 is supported by one of the support arms 72 and is actuatedby one of the pull wires 76. To facilitate smoother opening of thesupport arms 72 into the configuration depicted in FIG. 6B, it ispreferable to surround the support arm 72 and the pull wire 76 thatterminate at each individual anchor launcher 74 in a sleeve 79. In theFIG. 6B embodiment, there will be one sleeve 79 for each of the anchorlaunchers 74, and the support arms 72 and the pull wires 76 for thatanchor launchers 74 will run through the center of the correspondingsleeve 79. In some embodiments, these sleeves 79 are made from clearshrink tubing with an inner diameter (after shrinking) that is largeenough so as not to interfere with the slidability of the pull wires 76within the sleeves 79. In alternative embodiments, the sleeves 79 may bemade from other polymer materials with a similar inner diameter.

Preferably, an additional sleeve 89 is provided, and the proximalportions 84 of the cinching cord run through this additional sleeve 89.The sleeve 89 is similar to the sleeve 79 discussed above, and isdimensioned to have an inner diameter that is large enough so as not tointerfere with the slidability of the proximal portions 84 of thecinching cord within the sleeve 89.

In some embodiments, a retainer cord 78 is connected to the support arms72 and arranged with respect to the support arms 72 so that when theballoon 105 is disposed on a between the support arms 72 and inflated(as seen in FIG. 7D), the retainer cord 78 will encompass the balloon105 and prevent the balloon 105 from slipping out between the supportarms 72.

The retainer cord 78 may be connected to the support arms 72 using atleast one knot. In some embodiments, the retainer cord 78 comprises asilk suture. In alternative embodiments, the retainer cord 78 comprisesa polymer (e.g., nylon, polypropylene, polyester, etc.) cord.

In some preferred embodiments, the support arms 72 are enclosed insleeves 79 as described above, and the retainer cord 78 is connected tothe support arms 72 by threading the retainer cord 78 through a hole ineach of the sleeves 79 and tying a knot at each of the sleeves 79. Thismay be accomplished, for example, using a continuous surgical silksuture or a polymer cord that is connected between each of the supportarms 72 and its adjacent neighbor in sequence. The retainer cord 78 maybe attached to the support arms 72 by having an assembler puncture eachsleeve 79 with the integral needle of a surgical suture that willultimately serve as the retainer cord 78. After making the puncture, theretainer cord 78 is passed through the puncture and is fastened to thesleeve 79 using a knot (such as an overhand knot). The assembler thencontinues to the next support arm 72 and sleeve 79 and repeats the sameprocess, eventually returning to the first support arm 72 and sleeve 79.When this process is used to connect the retainer cord 78 to the supportarms 72, it is preferable to ensure that none of the knots enclose anyof the pull wires (so as not to interfere with the pull ability of thepull wires).

In alternative embodiments (not shown), the single retainer cord 78 thatis attached to each of the support arms 72 may be replaced with two ormore shorter segments of retainer cord, such that the shorter segmentsof retainer cord, collectively taken together, encompass the balloon andprevent the balloon from slipping out between the support arms.

FIGS. 7A-D depict using the FIG. 1-6 embodiments described above toinstall a cinching cord onto the mitral valve annulus of a humansubject, at sequential stages in time. In this example, the distal endof the apparatus 25 is routed through the subject's jugular and superiorvena cava into the right atrium of the subject's heart 30 with the outersleeve 60 in its extended position (as shown in FIG. 1). The distal tipis then passed through a puncture in the septum using any conventionalapproach and into the subject's left atrium 32.

FIG. 7A depicts the apparatus after the distal end of the apparatus hasreached the left atrium 32, and the outer sleeve 60 has been partiallyretracted. The anchor launchers 74 and the distal loop portion 82 of thecinching cord (which is disposed inside the sleeve 86) extend distallybeyond the distal end of the outer sleeve 60. The nosecone 100 mountedon the shaft 101 is lowered into the left ventricle 33 of the subject'sheart. Note that at this point in the sequence, only a portion of thesupport arms 72 extend distally beyond the distal end of the outersleeve 60, and the distal loop portion of the cinching cord (withinsleeve 86) remains partially collapsed.

FIG. 7B depicts the same apparatus after the outer sleeve 60 has beenfully retracted. Now, the anchor launchers 74, the distal loop portionof the cinching cord (which is disposed inside the sleeve 86), thesupport arms 72, the ends of the pull wires 76, the balloon 105, and theballoon retainer 78 all extend distally beyond the distal end of theouter sleeve 60. At this point, spring action of the support arms 72 hasopened up the distal loop portion of the cinching cord (within sleeve86) significantly.

FIG. 7C depicts the same apparatus after the balloon 105 has beeninflated. The balloon retainer 78 prevents the balloon 105 from slippingout between the support arms 72. The anchor launchers 74, the distalloop portion of the cinching cord (within the sleeve 86), the supportarms 72, the ends of the pull wires 76, the balloon 105, and the balloonretainer 78 all remain distally beyond the distal end of the outersleeve 60. At this point, the balloon 105 has pushed the support armsaway from each other, to help move the support arms 72 into a positionwhere they hold the distal ends of the anchor launchers 74 at positionsthat correspond to a shape of the annulus, with the distal ends of theanchor launchers 74 distributed about a perimeter of the shape of theannulus. Preferably, the support arms 72 have been pre-formed (asdescribed above in connection with FIG. 6A) so that none of the anchorlaunchers 74 will be positioned on or adjacent to the AV node to preventpotential damage to that node.

The distal ends of the anchor launchers 74 are pressed against theannulus and, after proper positioning has been confirmed (e.g. usingfluoroscopy), the anchor launchers 74 are triggered by pulling on theproximal ends of the pull wires 76. This causes each of the anchorlaunchers 74 to launch its anchor into the annulus. Preferably, all ofthe anchors launchers 74 are triggered simultaneously. This ispreferable because before anchors are launched, the structural shape ofthe support arms 72 determines the location and shape of the distal loopportion 82 of the cinching cord around the annulus. (In contrast, oncethe distal loop portion 82 is disconnected from the support arms 72, itcan be very difficult to control the shape of the implant. As a result,in alternative embodiments in which the anchors are launchedsequentially instead of simultaneously, the position of each anchorlauncher 74 might require adjustment prior to launching, which can bevery challenging.)

FIG. 7D depicts the same apparatus immediately after the anchors 75 havebeen launched into the annulus. At this point in the sequence, theanchors 75 have been deployed, and they hold the distal loop portion 82of the cinching cord (within the sleeve 86) to the annulus. The proximalportions 84 of the cinching cord remain connected to the distal loopportion of the cinching cord, but the delivery system (e.g. the supportarms 72, the anchor launchers 74, etc.) are no longer connected to thedistal loop portion 82 of the cinching cord.

Next, the balloon 105 is deflated and the balloon 105, the support arms72, and the anchor launchers 74 are pulled back into the outer sleeve 60as shown in FIG. 8A. These components are then pulled further back intothe outer sleeve 60 as shown in FIG. 8B. The anchors 75 continue to holdthe distal loop portion 82 of the cinching cord (within the sleeve 86)to the annulus 35, and proximal portions 84 of the cinching cord remainconnected to the distal loop portion of the cinching cord.

FIG. 9A is a detail of the proximal portion of the apparatus 25 shown inFIG. 5A. This detail depicts a portion of the housing 40, at least onespool 150, and a removable locking pin 155. The at least one spool 150is rotatably mounted with respect to the housing. The locking pin 155selectively either (a) prevents the at least one spool 150 from rotatingwhen the pin 155 is installed or (b) allows the at least one spool 150to rotate when the pin 155 is removed. The at least one spool isarranged with respect to the housing so that at least a portion of theat least one spool is visible from outside the housing.

In some preferred embodiments, the at least one spool has spokes 152that enhance visibility of rotation of the at least one spool 150, andthe at least one spool 150 is arranged with respect to the housing 40 sothat at least a portion of the spokes 152 is visible from outside thehousing 40. In alternative embodiments, the at least one spool hasmarkings (not shown) that enhance visibility of rotation of the at leastone spool 150, and the at least one spool 150 is arranged with respectto the housing 40 so that at least a portion of the markings is visiblefrom outside the housing 40.

FIG. 9B depicts a cutaway view of a preferred embodiment in which the atleast one spool 150 comprises a single spool having (a) a first region150 a upon which the proximal section of a first extension section ofcord 184 is wound and (b) a second region 150 b upon which the proximalsection of a second extension section of cord is wound. The first region150 a and the second region 150 b are non-overlapping. In alternativeembodiments, two independent spools (not shown) may be used in place ofa single spool that includes two regions 150 a and 150 b.

The first and second extension sections of cord 184 each has a distalend and a proximal section, and the distal end of these extensionsections is connected to the first and second proximal portions 84 ofthe cinching cord. The proximal sections of the first and secondextension sections or cord 184 are wound on the at least one spool 150.

Preferably, the entire cinching cord (including the distal loop portion82 and both proximal portions 84 of the cinching cord), the firstextension section of cord 184, and the second extension section of cord184 are contiguous sections of a single high tensile strength cord. Insome preferred embodiments, this single cord is a Dyneema cord. In somepreferred embodiments, this single cord is an ultra-high molecularweight polyethylene cord. In alternative embodiments, the extensionsections of cord 184 are not contiguous with the cinching cord. Instead,in these embodiments, the distal end of the first extension section ofcord 184 is fastened to the first proximal portion 84 of the cinchingcord, and the distal end of the second extension section of cord 184 isfastened to the second proximal portion 84 of the cinching cord (e.g.using a suitable adhesive).

The cinching cord has a distal loop portion 82 (shown in FIG. 8B), andfirst and second proximal portions 84 (shown in FIG. 8B). The first andsecond proximal portions 84 of the cinching cord extend distally beyondthe distal end of the core 50, and run through lumens 52 in the core 50(shown in FIG. 4A). The first and second proximal portions 84 of thecinching cord also extend proximally beyond the proximal end of the core(shown in FIG. 5C). The lumens 52 are dimensioned to slidablyaccommodate the first and second proximal portions 84 of the cinchingcord and also the first and second extension sections 184 of cord.

The cinching cord 82, 84, the first and second extension sections 184 ofcord, the lumens 52, and the at least one spool 150 are configured sothat after the distal loop portion 82 of the cinching cord is anchoredto the annulus or into the tissue adjacent to the annulus by the atleast four anchors 75 (shown in FIG. 8B) and the locking pin 155 (shownin FIG. 9A) has been removed, progressive movement of the housing 40 ina proximal direction will (a) cause the core 50 to progressively move ina proximal direction with respect to the first and second proximalportions 84 of the cinching cord and (b) cause the first and secondextension sections 184 of cord to progressively unwind from the at leastone spool and be progressively drawn into the lumens 52, respectively.

Preferably, the first and second proximal portions 84 of the cinchingcord and the first and second extension sections 184 of cord passthrough the lumens 52 with very low friction so that when the housing 40is moved in the proximal direction, the anchors that hold the distalloop portion 82 of the cinching cord to the annulus will not bedislodged. Lumens 52 that have smooth polymer walls (e.g. polyethylene,polyurethane, pebax, etc.) are suitable for this purpose.

Movement of the housing 40 in the proximal direction continues, and theextension section of cord 184 will continue to unwind from the at leastone spool 150 until the entire apparatus 25 (shown in FIG. 1) has beenremoved. At this point, the distal loop portion 82 of the cinching cordremains attached to the annulus (as shown in FIG. 8B), and the proximalportions 84 of the cinching cord run from the annulus back through thepatient's vasculature to an exit point (e.g. via the superior vena cavaand the jugular vein).

The preferred embodiments rely on tissue ingrowth to strengthen the bondbetween the distal loop portion 82 of the cinching cord and the annulus.In the FIG. 8B embodiment, the distal loop portion 82 of the cinchingcord is attached to the annulus by anchoring the sleeve 86 (throughwhich the distal loop portion 82 runs) to the annulus using the anchors75. Preferably, the sleeve 86 is made of a material that promotes tissueingrowth (e.g., a fabric braid). Immediately after implantation, thebond between the distal loop portion 82 the annulus is typically notstrong enough to withstand cinching. But because the sleeve 86 is madeof material that accepts tissue ingrowth, ingrowth of tissue at theannulus into the sleeve 86 will begin to occur after implantation. Thistissue ingrowth will eventually (e.g. over the course of 2-12 weeks)strengthen the bond between the sleeve 86 and the annulus until the bondis strong enough to withstand cinching.

It is preferable if the cinching cord 82, 84 has the ability to movefreely when cinching is eventually implemented. One preferred approachfor facilitating this freedom of movement is to line the sleeve 86 witha material that inhibits tissue ingrowth (e.g., ePTFE, polyurethane,etc.) which will ensure that the distal loop portion 82 of the cinchingcord will be able to move freely within the sleeve 86 when cinching iseventually implemented.

During the time that tissue ingrowth is strengthening the bond betweenthe sleeve 86 and the annulus (which is desirable), tissue ingrowth canalso occur between the proximal portions 84 and the vasculature throughwhich those proximal portions travel. The latter type of ingrowth is notdesirable because it could interfere with the ability of the proximalportions 84 to move freely when cinching is eventually implemented. Onepreferred approach for preventing tissue ingrowth between the proximalportions 84 of the cinching cord and the vasculature through which thoseproximal portions travel is to (a) slide a cord protector over theproximal portions of the cinching cord, and (b) leave the cord protectorin place between the time that the distal loop portion 82 of thecinching cord is implanted and the time that cinching eventually occurs.

FIG. 10A depicts a suitable cord protector for this purpose. Morespecifically, FIG. 10A depicts a cord protector for preventing tissueingrowth from interfering with the operation of a cinching cord that isimplanted in a subject's body. The cord protector has a flexibleelongated body 120 having a proximal end and a distal end. The elongatedbody 120 has first and second lumens 122 that run between the proximalend and the distal end of the body 120. The lumens 122 are dimensionedto slidably accommodate the proximal portions of the cinching cord. Thebody 120 and the lumens 122 are configured to facilitate slidableinstallation of the body 120 over the first and second proximal portionsof the cinching cord such that the elongated body 120 covers the firstand second proximal portions of the cinching cord, with the first andsecond proximal portions disposed in the first and second lumens 122,respectively. The body 120 prevents tissue ingrowth into the elongatedbody itself, and also prevents tissue ingrowth into the first and secondproximal portions of the cinching cord when the elongated body 120covers the first and second proximal portions of the cinching cord.

In some embodiments, the body 120 is formed from at least one ofpolyurethane and silicone. In some embodiments, the body 120 is formedfrom Pellethane 55D polyurethane. In some embodiments, the body 120 hasa length between 35 and 65 cm and a diameter between 1 and 4 mm. In someembodiments, the body 120 has a length between 45 and 55 cm and adiameter between 1.5 and 2.5 mm. Suitable diameters for the first andsecond lumen 122 range between diameter between 0.2 and 1 mm.

Optionally, the body 120 may have a third lumen 123 that is open at theproximal end, closed at the distal end, and extends through at leastthree-fourths of the elongated body. This third lumen is dimensioned toslidably accommodate a stiffening wire, which can be useful insituations where the body 120 is insufficiently stiff to be guided toits intended destination on its own. In some embodiments, the diameterof the third lumen 123 is between 0.2 and 1 mm.

Optionally, a radio-opaque marker 125 (e.g. 80% platinum and 20%iridium, or other alternatives that will be apparent to persons skilledin the relevant arts) may be added, preferably disposed near the distalend of the elongated body. Optionally, an ePTFE capping sleeve (notshown) may be added to the cord protector.

FIG. 10B depicts the cord protector of FIG. 10A combined with a set ofthreading cords 128. The first and second threading cord 128 run throughthe first and second lumens and extend distally beyond the distal end ofthe elongated body. The first and second threading cords 128 areconfigured to draw the first and second proximal portions of thecinching cord into the first and second lumens 122, respectively, sothat the first and second proximal portions of the cinching cord canoperate as guidewires over which the elongated body 120 can be slid intoa position at which the distal end of the elongated body 120 is adjacentto the distal loop portion of the cinching cord. Suitable materials forthe threading cords 128 include nitinol and stainless steel. Optionally,both the cord protector and the threading cords 128 may be packagedinside a sterile envelope.

FIG. 11 depicts a method for preventing tissue ingrowth from interferingwith the cinching of an annulus using a cinching cord. In step S10, thecinching cord is manipulated so that (a) a distal loop portion of thecinching cord (disposed within a sleeve) is in the vicinity of theannulus and (b) the first and second proximal portions of the cinchingcord run in a proximal direction from the distal loop portion of thecinching cord back through the vasculature of the subject (as depictedin FIG. 7C). In step S20, the distal loop portion of the cinching cordis anchored to at least one of the annulus and tissue adjacent to theannulus. This step is preferably implemented by anchoring the sleeve toat least one of the annulus and the tissue adjacent to the annulus usinga plurality of anchors (as depicted in FIG. 8B).

In step S25, which is optional, a stiffening member (e.g., a metal wire)is slid in a proximal to distal direction through a third lumen thatruns through the elongated cord protector. Then, in step S30, the firstand second proximal portions of the cinching cord are covered with thecord protector which is made from a material that resists tissueingrowth. The covering step may be implemented by sliding an elongatedcord protector with two lumens over the first and second proximalportions of the cinching cord so that the proximal portions of thecinching cord pass through the lumens (as depicted in FIG. 12A and FIG.12B).

After the anchoring step and the covering step, in step S40 we wait fortissue ingrowth to strengthen a bond between the distal loop portion ofthe cinching cord and at least one of the annulus and the tissueadjacent to the annulus. In some embodiments, the waiting step compriseswaiting at least two weeks. But it is often preferable to wait at leasttwo months to ensure that the bond is strong enough to withstandcinching. In many cases, waiting at least three months is advisable toensure that the bond is strong enough to withstand cinching.

After the waiting step, the cord protector is removed in step S50 (asdepicted in FIG. 13A).

The annulus is then cinched in step S60 by pulling the first and secondproximal portions of the cinching cord so as to reduce a diameter of theannulus. Cinching may be implemented by advancing a thrust tube 130 in adistal direction over the first and second proximal portions 84 of thecinching cord until the thrust tube 130 reaches the distal loop portion82 of the cinching cord and subsequently pressing the thrust tube 130 ina distal direction while pulling the first and second proximal portions84 of the cinching cord in a proximal direction (as depicted in FIG.13B).

After the cinching step, the cinching cord is fastened in step S70 sothat the cinching cord holds the annulus in a reduced diameter state.This step may be implemented by fastening two portions of the cinchingcord together using at least one of a knot, a clamp, and a crimpedfastener.

Note that FIGS. 2 and 6 depicts the support arms 72 holding the distalloop portion 82 of the cinching cord in a round configuration prior toimplantation, and FIGS. 8, 12, and 13 show the distal loop portion 82 ina round configuration subsequent to implantation. In alternativeembodiments (e.g. for installation in a human mitral valve annulus,which is D-shaped) the support arms 72 are shaped to hold the distalloop portion 82 of the cinching cord in a D-shaped configuration priorto implantation, which will result in a D-shaped distal loop portion 82subsequent to implantation.

FIG. 14 depicts an alternative embodiment that is similar to the FIG.1-8 embodiment discussed above, except that the FIG. 14 embodimentincludes a second balloon mounted on a second shaft. More specifically,the FIG. 14 embodiment adds a second shaft 108 that is slidably disposedwithin the main channel 55. This second shaft had a second inflationlumen. The FIG. 14 embodiment also adds an inflatable second balloon 107mounted to the second shaft 108 and connected to the second inflationlumen so as to permit inflation of the second balloon 107 via the secondinflation lumen. The second balloon 107 is disposed distally beyond thefirst balloon 105. The second shaft 108 is preferably coaxially arrangedwith respect to the first shaft 106 (i.e., the shaft for the firstballoon 105), with the first shaft 106 disposed and configured so thatboth shafts can move independently in a proximal-to-distal direction.

In some preferred embodiments, the second shaft 108 is the innermostshaft, and the first shaft 106 (shown in FIG. 3) coaxially surrounds thesecond shaft 108, and the core 50 (also shown in FIG. 3) coaxiallysurrounds the first shaft 106. Optionally, a lumen (not shown)dimensioned to accommodate a guidewire may be disposed within the secondshaft 108. In some preferred embodiments, this lumen is dimensioned toaccommodate a 0.035 inch diameter guidewire.

In some embodiments (including the embodiment depicted in FIG. 14), thesecond shaft 108 extends distally beyond the nosecone 100 and the secondballoon 107 is located distally beyond the nosecone 100. In theseembodiments, the nosecone 100 may be mounted to the second shaft 108(i.e. the same shaft to which the second balloon 107 is mounted), oralternatively, the nosecone 100 may be mounted on its own dedicatedthird shaft (not shown). In the latter situation, the third shaft ispreferably slidably disposed within the main channel 55, and thenosecone 100 is movable between a proximal position and a distalposition by slidably adjusting the position of the third shaft. Thethird shaft is preferably coaxially arranged with respect to the firstshaft 106 and the second shaft 108, and configured so that all threeshafts can move independently in a proximal-to-distal direction.

In alternative embodiments (not shown) the nosecone 100 is locateddistally beyond the second balloon 107. In these embodiments, thenosecone 100 may be mounted to a portion of the same second shaft 108that extends distally beyond the second balloon 107.

It is preferable to launch the anchor launchers 74 when the distal endsof the anchor launchers are pressed against the annulus or against thetissue adjacent to the annulus, and the second balloon 107 can be usedin different ways to help press the anchor launchers against the annulusor tissue depending on the anatomical context in which the cinching cordis being installed.

In one example, when the cinching cord is being installed at thetricuspid valve annulus, the distal assembly 70 (shown in FIG. 6B) ispositioned in the right atrium and the second balloon 107 (shown in FIG.14) is advanced in the deflated state into the pulmonary artery past thebifurcation (i.e., into the right pulmonary artery or into the leftpulmonary artery). The second balloon 107 is been inflated. When thesecond balloon 107 is inflated at this position, it will act as atemporary anchor to assist in maneuvering the distal assembly 70 towardthe annulus plane and gently press the ring against the annulus duringanchor deployment.

In another example, when the cinching cord is being installed at themitral valve annulus, when the second balloon 107 is positioned near themiddle of the subject's ventricle (e.g., the left ventricle 33) andinflated, movement of the heart walls and/or movement of the bloodtraveling through the heart during a selected portion of the cardiaccycle (e.g., one of systole, diastole, etc.) will exert a force thaturges the second balloon 107 towards the apex of the heart. Thisphenomenon can be taken advantage of to press the distal ends of theanchor launchers 74 against the annulus. The second balloon 107 and theassembly that includes the anchor launchers 74 are supported by the samesupporting member (e.g., the core 50 depicted in FIG. 3). The triggeringof the anchor launchers 74 can then be timed to coincide with thepressing that occurs during the selected portion of the cardiac cycle.

FIG. 15 is a flowchart of a method for using the dual-balloon embodimentof FIG. 14 to implement a method for implanting an annulus ring or acinching cord to a heart valve annulus (or into tissue adjacent to theannulus). The annulus is disposed between an atrium and a ventricle ofthe heart. This method includes step S100 in which an assembly isdelivered into the atrium. The assembly includes (a) the annulus ring orthe cinching cord, (b) a plurality of anchors connected to the annulusring or the cinching cord, and (c) a plurality of anchor launchersconfigured to launch the anchors into the annulus or into the tissueadjacent to the annulus. The assembly is supported by a supportingmember (e.g., the core 50, shown in FIG. 3).

Next, in step S110, the assembly is positioned such that the annulusring or the cinching cord is adjacent to the annulus or the tissueadjacent to the annulus on the atrium side of the annulus. In step S120,an inflatable balloon is advanced into the ventricle. The balloon issupported by the same supporting member that supports the assembly. Instep S130, the balloon is inflated while the balloon is in theventricle. The position of the balloon within the ventricle is adjustedin step S140 so that when the selected portion of the cardiac cycleoccurs while the balloon is inflated, forces on the balloon will urgethe balloon toward the apex of the heart, which will urge the supportingmember toward the apex of the heart, which will urge the annulus ring orthe cinching cord towards the annulus or towards the tissue adjacent tothe annulus. Next, in step S150, while the inflated balloon is at theadjusted position, a time when the selected portion of the cardiac cycleis occurring is determined.

The anchor launchers are triggered in step S160 (e.g., by actuating thetrigger 47 after removal of the locking pin 48, both shown in FIG. 5C)so that the anchor launchers launch the anchors into the annulus or intothe tissue adjacent to the annulus during the selected portion of thecardiac cycle while the inflated balloon is at the adjusted position.

In some embodiments, the determining in step S150 comprises detectingwhen the supporting member is being pulled in a distal direction. Insome embodiments, the advancing in step S120 comprises sliding a shaftto which the inflatable balloon is mounted in a distal direction withrespect to the supporting member. In some embodiments, the positioningin step S110 comprises inflating the first balloon 105 between aplurality of support arms 72 that support the anchor launchers 74 sothat the additional balloon 105 pushes the support arms 72 away fromeach other (as depicted above in FIG. 7C).

In some embodiments, the delivering in step S100 comprises introducingthe annulus ring or the cinching cord, the anchors, and the anchorlaunchers into the atrium while the cinching cord, the anchors, and theanchor launchers are collapsed within an outer sleeve; and retractingthe outer sleeve so that the cinching cord, the anchors, and the anchorlaunchers extend beyond a distal end of the outer sleeve.

FIG. 16 depicts a variation of the FIG. 6A embodiment in which thecinching cord has been replaced by an annulus ring. In this embodiment,instead of implanting the distal loop portion 82 of a cinching cord intothe annulus so that the proximal portions 84 of the cinching cord extendback through the core 50 (as described above in connection with FIG.6A), a closed annulus ring 182 is implanted into the annulus or intotissue adjacent to the annulus. Preferably, the annulus ring 182 issurrounded by a sleeve 186 in a manner similar to the way that thedistal loop portion 82 of the cinching cord was enclosed in a sleeve 86in the FIG. 6A embodiment. Similarly, the cinching cord in any of theother embodiments discussed above can be replaced with an annulus ring.

When the apparatus 25 described above in connection with FIGS. 1-9 and14 is withdrawn from the patient's body, the possibility exists that acomponent (e.g., the anchor launchers 74, the support arms 72, theballoon 105, the outer sleeve 60, etc.) that is moving in a proximaldirection will grab against the proximal portions of the cinching cord84. (See, for example, FIGS. 8A and 8B.) If this occurs, the forces onthe proximal portions of the cinching cord 84 would pull on the distalloop portion of the cinching cord 82, and those forces might besufficient to dislodge one or more of the anchors 75 from the annulus35.

FIGS. 17 and 18 depict one optional approach to prevent dislodgment ofthe anchors 75 in these circumstances. This embodiment is similar to theFIG. 1-9 embodiment described above, but adds additional components210-222 reduce the risk of dislodgment. FIG. 17 depicts the distalportion of the apparatus just prior to launching of the anchors 75 fromthe anchor launchers 74; and FIG. 18 depicts the same apparatus afterthe anchors 75 have been implanted in the annulus 35 and withdrawal ofthe apparatus has begun.

As best seen in FIGS. 1, 3, and 4A, the apparatus includes a housing 40and an elongated core 50 mounted with respect to the housing 40. Thecore has at least one second channel 52 that runs through the core in aproximal-to-distal direction, and at least one fourth channel (notshown) that runs through the core in a proximal-to-distal direction.These fourth channels resemble the second channels 52 described above inconnection with FIG. 4A. In some preferred embodiments, there are twosecond channels and two fourth channels.

A cinching cord has a distal loop portion and first and second proximalportions 84. The proximal portions of the cinching cord are slidablydisposed within the at least one second channel and extend distallybeyond the distal end of the core. In some preferred embodiments, eachproximal portion of the cinching cord is disposed within its ownindividual lumen.

Turning now to FIG. 17, at least four support arms 72 are mounted to thecore and extend distally beyond the distal end of the core. At leastfour anchors 75 (shown in FIG. 18) are configured to anchor the distalloop portion of the cinching cord into the annulus or into the tissueadjacent to the annulus. (Note that in FIG. 17, the distal loop portionof the cinching cord is covered by a sleeve 86 of material that promotestissue ingrowth.) At least four anchor launchers 74 are supported by arespective one of the support arms 72, and each anchor launcher isconfigured to launch a respective one of the anchors into the annulus orinto the tissue adjacent to the annulus.

At least one wire 215 is slidably disposed within the at least onefourth channel. Each of these wires has a distal end that extendsdistally beyond the distal end of the core, and has a proximal end thatextends proximally beyond the fourth channel. In some preferredembodiments, the at least one wire comprises two wires, and the at leastone fourth channel comprises two channels, with each of the two wiresslidably disposed within a respective one of the two channels. In somepreferred embodiments, each of these wires 215 is a Nitinol wire with adiameter between 0.3 and 0.5 mm (e.g., 0.4 mm).

A pushing member 210 is affixed to the distal end of the at least onewire 215 such that pushing the proximal end of the at least one wire 215in a distal direction will push the pushing member 210 in a distaldirection. In some embodiments (including the FIG. 17 embodiment), thepushing member 210 is a hollow cylinder aligned so that an axial axis ofthe hollow cylinder is parallel to the at least one wire 215, and thefirst proximal portion and the second proximal portion of the cinchingcord 84 pass through the interior of the hollow cylinder and areslidably disposed therein. In some embodiments, the pushing member 210is a hollow cylinder that is laser cut from a nitinol tube with an outerdiameter between 1.25 and 2 mm (e.g., 1.63 mm). In some embodiments, thehollow cylinder has relatively large wall thickness (e.g., 0.23 mm), andthe edges of the cylinder are radiused (e.g., by electropolishing) toreduce the risk of damaging the proximal portions of the cinching cord84 when those proximal portions slide through the cylinder.

It is preferable to use a plurality of wires 215 that terminate on thepushing member 210 (as compared to a single wire 215) to improvepushability and stability.

The FIG. 17/18 embodiment also includes an optional crush resistantchannel 220 disposed distally beyond the distal end of the core.Preferably, the inner walls of the crush resistant channel 220 are madefrom a low friction material. The first and second proximal portions ofthe cinching cord 84 are slidably disposed within this crush resistantchannel. Preferably, the space between the distal end of the core andthe proximal end of the crush resistant channel is kept as small aspossible. In some embodiments, this crush resistant channel 220 isconfigured so that prior to launching of the anchors, the crushresistant channel 220 extends all the way to the pushing member 210, asdepicted in FIG. 17. One suitable approach for implementing this crushresistant channel 220 is to use a Pebax tube reinforced by a polyesterbraid, with an inner diameter on the order of 1 mm. The crush resistantchannel 220 prevents the support arms 72 and the anchor launchers 74from grabbing against the proximal portions of the cinching cord 84(which passes through the crush resistant channel 220) when thosecomponents 72, 74 are withdrawn.

In some embodiments, the crush resistant channel 220 is supported by atleast one support arm that is affixed to the core. These support armsmay have a similar construction to the support arms 72 that hold theanchor launchers 74, and may be connected to the core in the same way asthose support arms 72, as described above. The crush resistant channel220 may be attached to its support arm using, for example, heat shrinktubing and/or an adhesive.

After the anchor launchers have been maneuvered to the desired positionadjacent to the annulus 35, launching of the anchors proceeds in thesame way as described above in connection with FIGS. 7A-7D.

Turning now to FIG. 18, after the anchors have been launched, the distalloop portion of the cinching cord (which, in FIG. 18, runs through theinterior of sleeve 86) is anchored to the annulus 35 (or into the tissueadjacent to the annulus) by the anchors 75. The core is then pulled backthrough the outer sleeve 60, which causes the support arms 72 and thecrush resistant channel 220 to move in a proximal direction. While thecore is pulled back, an operator pushes the wires 215 in a distaldirection, which will urge the pushing member 210 against the tissue ofthe annulus 35, as depicted in FIG. 18. Because the proximal portions ofthe cinching cord 84 are threaded through a passage that extends throughthe pushing member 210 in a proximal to distal direction (e.g. theinterior of a hollow cylinder), the distal end of the pushing memberwill hold the proximal portions of the cinching cord 84 against thetissue. This will hinder dislodgement of the anchors 75 during themovement of the housing in the proximal direction, by eliminating (or atleast reducing) forces that might otherwise tend to pull the anchors 75out of the tissue.

Progressive movement of the housing 40 (shown in FIG. 1) in a proximaldirection will cause the core 50 (also shown in FIG. 1) to progressivelymove in a proximal direction with respect to the first and secondproximal portions of the cinching cord 84. The point in time depicted inFIG. 18 is when the core has been withdrawn a few centimeters, so thatthe support arms 72 and the anchor launchers 74 begin to collapse andare pulled back into the outer sheath 60. Because the proximal portionsof the cinching cord 84 pass through the crush resistant channel 220,that channel will protect the proximal portions of the cinching cord 84from being grabbed by the support arms 72 and the anchor launchers 74when those components are moved in a proximal direction.

Withdrawal of the entire apparatus then proceeds while the operatorcontinues to press the wires 215 in a distal direction. Once the entireapparatus 25 has been removed, the operator can release the distalpressure on the wires 215, and pull those wires out of the patient'sbody in a proximal direction. The wires 215 will pull the pushing member210 out of the patient's body. As this occurs, the proximal portions ofthe cinching cord 84 will slide through the passage in the interior ofthe pushing member 210 until the pushing member 210 has been completelywithdrawn.

FIG. 19 depicts another embodiment that is similar to the embodimentdescribed above in connection with FIG. 14, but (a) deletes the noseconefrom the FIG. 14 embodiment; and (b) replaces the outer sleeve 60 of theFIG. 14 embodiment with a two-part sleeve that includes a first sleeve62 and a second sleeve 65. Note that this two-part sleeve configurationmay be used in place of the single outer sleeve 60 in any of theembodiments described herein.

The first sleeve 62 in the FIG. 19 embodiment is similar to the outersleeve 60 in the FIG. 14 embodiment, except that the first sleeve 62 isshorter than the outer sleeve 60 in the FIG. 14 embodiment. Morespecifically, the length of the first sleeve 62 is such that even whenthe first sleeve 62 is in its most extended position, the anchorlaunchers are not covered by the first sleeve 62.

A second sleeve 65 is disposed at the distal end of the apparatus, andthis second sleeve 65 covers the distal end of the first sleeve 62 andextends distally beyond the distal end of the first sleeve 62 to coverthe anchor launchers. The inner diameter of the second sleeve 65 isslightly larger than the outer diameter of the first sleeve 62 in orderto permit the first sleeve 62 to slide within the second sleeve 65. Thesecond sleeve 65 is preferably configured so that it can be torn apart(e.g., by pulling on tabs 66) and removed. An example of a commerciallyavailable component that is suitable for use as the second sleeve 65 isthe 22 French outer sleeve component from the Cook Medical Peel-Away®introducer set (Ref. Nos. C-PLI-22.0-38 and G04518).

This embodiment is particularly useful for accessing the tricuspidannulus when used in conjunction with an introducer sheath such as theGORE® DrySeal Sheath, which should have the same outer diameter as thesecond sleeve 65 (e.g., 22 French). To access the tricuspid annulususing this embodiment, the distal end of a GORE® DrySeal Sheath isintroduced via the jugular and advanced until it enters the rightatrium. A guide wire is then routed through the DrySeal Sheath, throughthe annulus into the right ventricle, and into the pulmonary arteryuntil it passes the bifurcation in the pulmonary artery in eitherdirection, and enters either the right pulmonary artery or the leftpulmonary artery.

The distal balloon 107 (shown in FIG. 14) is advanced over the guidewireand into the DrySeal Sheath. The entire device (including, but notlimited to the second sleeve 65) is then advanced in a distal directionuntil the distal end of the second sleeve 65 reaches the proximalentrance of the DrySeal Sheath. Because the outer diameter of the secondsleeve 65 is the same as the outer diameter of the DrySeal Sheath, thesecond sleeve 65 will not be able to move into the DrySeal Sheath. Thedistal balloon 107 is threaded over the guidewire. Next, the entiredevice except for the second sleeve 65 (which is blocked by the DrySealSheath) is advanced in a distal direction, so that the first sleeve 62slides in a distal direction within the second sleeve 65. The distalassembly 70 will slide through the second sleeve 65 and into the DrySealSheath, after which the distal end of the first sleeve 62 will slideinto the DrySeal Sheath. At this point, the operator pulls on the tabs66 of the second sleeve 65 and removes that sleeve. Subsequently,advancing of the entire device continues until the distal assembly 70exits the distal end of the DrySeal Sheath. At this point, the DrySealSheath may be withdrawn a few centimeters to improve maneuverability ofthe distal assembly 70 within the right atrium.

The distal assembly 70 is then advanced with respect to the first sleeve62 and the DrySeal Sheath, until the support arms 72 can pop open due tospring action or a shape-memory effect. The distal balloon is then movedinto the pulmonary artery beyond the bifurcation in either direction andinflated. The orientation of the distal assembly 70 is adjusted e.g.,using the controls 42 or by moving the entire housing 40 so as toapproach the annulus. Fluoro guidance may be used for this purpose,optionally relying on the radio opaque sleeves 98. The proximal balloon105 is inflated to help spread the support arms 72 and so that thedistal assembly will move as a single unit. Optionally, the shaft 106 ofthe proximal balloon 105 may be locked at this point. Additionaladjustments to the orientation of the distal assembly are made, and theanchors are launched by actuating the trigger 47 for the spring-loadedactuator 46.

Pressure is applied to the pushing member 210 by pushing the wires 215distally, the balloons are deflated, and the DrySeal Sheath is advancedin a distal direction until the support arms 72 begin to collapse. Theentire device is then withdrawn by moving the housing 40 in a proximaldirection. The distal pressure on the pushing member 210 will squeezethe proximal portions of the cinching cord 84 against the tissue, whichwill prevent dislodgment of the anchors as described above. Continuedwithdrawal of the housing 40 will pull the support arms and the anchorlaunchers 74 in a proximal direction through the DrySeal Sheath (whilepushing on the pushing member 210 continues) until only the cinchingcord 82, 84 the surrounding sleeve 86, the anchors 75, the pushingmembers 210, and the pushing wires 215 remain. Finally, the pushingmembers 210, the pushing wires 215, and the DrySeal Sheath arewithdrawn.

While the present invention has been disclosed with reference to certainembodiments, numerous modifications, alterations, and changes to thedescribed embodiments are possible without departing from the sphere andscope of the present invention, as defined in the appended claims.Accordingly, it is intended that the present invention not be limited tothe described embodiments, but that it has the full scope defined by thelanguage of the following claims, and equivalents thereof.

What is claimed is:
 1. An apparatus for delivering an annulus ring or acinching cord to the vicinity of an annulus, the apparatus comprising:an elongated core having a distal end and a channel that runs throughthe elongated core in a proximal-to-distal direction; at least foursupport arms mounted to the elongated core that extend distally beyondthe distal end of the elongated core; at least four anchor launchers,each of the anchor launchers having a distal end, wherein each of theanchor launchers is supported by a respective one of the support arms; afirst shaft disposed within the channel, the first shaft having a firstinflation lumen; an inflatable first balloon mounted to the first shaftand connected to the first inflation lumen so as to permit inflation ofthe first balloon via the first inflation lumen, wherein the firstballoon is configured so that when the first balloon is inflated at afirst position, the first balloon will push the support arms away fromeach other; a second shaft slidably disposed within the channel, thesecond shaft having a second inflation lumen; and an inflatable secondballoon mounted to the second shaft and connected to the secondinflation lumen so as to permit inflation of the second balloon via thesecond inflation lumen, wherein the first shaft and the second shaft arecoaxial while the first balloon and the second balloon are both in adeflated state prior to inflation of either balloon, and the secondballoon is disposed distally beyond the first balloon.
 2. The apparatusof claim 1, wherein the first shaft is slidably disposed within thechannel, and the first balloon is movable to the first position byslidably adjusting a position of the first shaft.
 3. The apparatus ofclaim 2, wherein the first balloon is movable to a second position thatis within the channel and proximal of the support arms by slidablyadjusting a position of the first shaft.
 4. The apparatus of claim 1,further comprising an outer sleeve disposed around the elongated core,the outer sleeve having a distal end, wherein the outer sleeve isslidable with respect to the elongated core between an extended positionand a retracted position, wherein, when the outer sleeve is in theextended position, the support arms, the anchor launchers, and the firstballoon are disposed within the outer sleeve, and wherein, when theouter sleeve is in the retracted position, the anchor launchers and atleast a portion of the support arms extend distally beyond the distalend of the outer sleeve.
 5. The apparatus of claim 4, further comprisinga nosecone that is movable between a proximal position and a distalposition, such that when the nosecone is in the proximal position andthe outer sleeve is in the extended position, the nosecone is disposedat the distal end of the outer sleeve.
 6. The apparatus of claim 5,wherein the second shaft extends distally beyond the nosecone and thesecond balloon is located distally beyond the nosecone.
 7. The apparatusof claim 5, wherein the nosecone is mounted to the second shaft, and thenosecone is movable between the proximal position and the distalposition by slidably adjusting a position of the second shaft.
 8. Theapparatus of claim 5, wherein the first shaft is slidably disposedwithin the channel, wherein the first balloon is movable to the firstposition by slidably adjusting a position of the first shaft, whereinthe second shaft extends distally beyond the nosecone and the secondballoon is located distally beyond the nosecone, wherein the nosecone ismounted to the second shaft, and wherein the nosecone is movable betweenthe proximal position and the distal position by slidably adjusting aposition of the second shaft.
 9. The apparatus of claim 5, furthercomprising a third shaft slidably disposed within the channel, whereinthe nosecone is mounted to the third shaft, and the nosecone is movablebetween the proximal position and the distal position by slidablyadjusting a position of the third shaft.
 10. The apparatus of claim 5,wherein the nosecone is located distally beyond the second balloon. 11.The apparatus of claim 1, further comprising: a cinching cord; and atleast four anchors, wherein each of the anchors is disposed in arespective one of the anchor launchers and connected to the cinchingcord, wherein the support arms are configured to hold the distal ends ofthe anchor launchers at positions that correspond to a shape of theannulus, with the distal ends of the anchor launchers distributed abouta perimeter of the shape of the annulus.
 12. The apparatus of claim 1,further comprising: an annulus ring; and at least four anchors, whereineach of the anchors is disposed in a respective one of the anchorlaunchers and connected to the annulus ring, wherein the support armsare configured to hold the distal ends of the anchor launchers atpositions that correspond to a shape of the annulus, with the distalends of the anchor launchers distributed about a perimeter of the shapeof the annulus.
 13. The apparatus of claim 1, wherein the at least foursupport arms comprises at least eight support arms, and wherein the atleast four anchor launchers comprises at least eight anchor launchers.14. The apparatus of claim 1, wherein the annulus is a mitral valveannulus.
 15. The apparatus of claim 1, wherein the annulus is atricuspid valve annulus.